Papers by Barbara Mintzes
BMJ Open, May 1, 2023
Objectives To understand how and why Australian cancer physicians interact with the pharmaceutica... more Objectives To understand how and why Australian cancer physicians interact with the pharmaceutical industry. Design Qualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes. Setting Given the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians' experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom. Participants 16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%). Outcome measures The analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped. Results Six themes were identified that fell within two broad categories: cancer physicians' views and experiences of interactions and management of these interactions. Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a 'middle road'. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome. Conclusions Cancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area. ⇒ This study is the first comprehensive qualitative analysis of cancer physicians' experiences interacting with the pharmaceutical industry. ⇒ Preplanned thematic analysis using combination of deductive and inductive codes. ⇒ Interviews with cancer physicians performed by a practising medical oncologist to encourage openness and honesty in discussions. ⇒ Limited to the Australian context. ⇒ Sole interviewer and analysis and predominantly limited to a sole coder.
If the aim of federal regulation of prescription drugs is to protect public health and to promote... more If the aim of federal regulation of prescription drugs is to protect public health and to promote safe, effective and informed medicine use, the first five years' experience with Diane-35 (cyproterone acetate and ethinyl estradiol) in Canada is a case study in regulatory failure. An examination of how and why this failure occurred provides an example of why changes are needed to federal drug regulation in Canada. This paper covers the period from pre-market application to the first five years postlicensing, late 2003. A systematic review of the studies provided to Health Canada to obtain regulatory approval was conducted, as well as a review of subsequent published studies, in order to examine the evidence supporting regulatory decisions both pre-and post-approval. Regulatory approaches to Diane-35 changed dramatically over time, with initial caution during the pre-marketing stage replaced by a laissez-faire approach during the initial post-market stages, and a renewal of caution following public and media criticism. Health Canada initially refused to approve the product because of safety concerns, and later limited the approved use in the hope of restricting population exposure. The limited criteria for approved use failed to limit population exposure due to a lack of monitoring and enforcement. Health Canada compounded the regulatory failure by failing to adequately enforce restrictions on advertising of Diane-35. Diane-35 has been widely advertised to the Canadian public, despite laws explicitly prohibiting such advertising.
BMJ, May 3, 2007
Columbia, the only Canadian province not to fund these drugs, the Alzheimer's Society claims that... more Columbia, the only Canadian province not to fund these drugs, the Alzheimer's Society claims that some people get greater than average benefits but did not support a provincial initiative for double blind n of 1 crossover trials to determine coverage. 18 Industry funded groups often exert strong pressure on governments to reimburse sponsors' drugs. Michael Rawlins, chair of NICE, warns, "In the long term it will do the patient organisations an immense amount of damage and the confidence in their neutrality will dissipate." 19 Governments increasingly include public representatives on advisory committees and European legislation now requires this of the European Medicines Agency. Despite conflict of interest guidelines, these representatives are often selected from industry funded patient groups and networks. The European Patients' Forum represents patients at the medicines agency and the European Union Pharmaceutical Forum. The forum was founded solely with industry funding and remains over 90% industry funded. 20 On its website, a report funded by Pfizer supports industry's "strong desire to provide more information than currently allowed" to consumers and patients. The Association of British Pharmaceutical Industry's call for members to disclose charity funding is a positive step. Better national regulations governing charities are needed, to ensure full, easily accessible, and consistent disclosure. Are such steps sufficient? From the evidence, it seems that even small donations can affect a group's stance. A consumer group funded by telephone companies would not be trusted to judge the best mobile phone package, nor to be a public advocate on telecommunications policy. Is health less important? Competing interests: BM is a research consultant with Health Action International, vice-president of DES (diethylstilboestrol) Canada, and on the Steering Groups of Women and Health Protection and Pharmawatch. These are consumer and patient groups without industry funding. She works with the Therapeutics Initiative, funded by the British Columbia Ministry of Health to carry out systematic drug reviews that are background reports for drug financing decisions, and as a clinical reviewer for Canada's Common Drug Review. References are in the full version on bmj.com
PLOS ONE, Jan 9, 2017
Medical faculties have a role in ensuring that their students are protected from undue commercial... more Medical faculties have a role in ensuring that their students are protected from undue commercial influence during their training, and are educated about professional-industry interactions. In North America, many medical faculties have introduced more stringent conflict of interest (COI) policies during the last decade. We asked whether similar steps had been taken in France. We hypothesized that such policies may have been introduced following a 2009-2010 drug safety scandal (benfluorex, Mediator) in which COIs in medicine received prominent press attention. We searched the websites of all 37 French Faculties of Medicine in May 2015 for COI policies and curriculum, using standardized keyword searches. We also surveyed all deans of medicine on institutional COI policies and curriculum, based on criteria developed in similar US and Canadian surveys. Personal contacts were also consulted. We calculated a summary score per faculty based on 13 criteria. [range 0-26; higher scores denoting stronger policies] In total, we found that 9/37 (24%) of French medical schools had either introduced related curriculum or implemented a COI-related policy. Of these, only 1 (2.5%) had restrictive policies for any category. No official COI policies were found at any of the schools. However, at 2 (5%), informal policies were reported. The maximum score per faculty was 5/26, with 28 (76%) scoring 0. This is the first survey in France to examine COI policies at medical faculties. We found little evidence that protection of medical students from undue commercial influence is a priority, either through institutional policies or education. This is despite national transparency
PLOS ONE, Apr 22, 2021
Assessing the process used to synthesize the evidence in clinical practice guidelines enables use... more Assessing the process used to synthesize the evidence in clinical practice guidelines enables users to determine the trustworthiness of the recommendations. Clinicians are increasingly dependent on guidelines to keep up with vast quantities of medical literature, and guidelines are followed to avoid malpractice suits. We aimed to assess whether systematic methods were used when synthesizing the evidence for guidelines; and to determine the type of review cited in support of recommendations. Guidelines published in 2017 and 2018 were retrieved from the TRIP and Epistemonikos databases. We randomly sorted and sequentially screened clinical guidelines on all topics to select the first 50 that met our inclusion criteria. Our primary outcomes were the number of guidelines using either a systematic or non-systematic process to gather, assess, and synthesise evidence; and the numbers of recommendations within guidelines based on different types of evidence synthesis (systematic or non-systematic reviews). If a review was cited, we looked for evidence that it was critically appraised, and recorded which quality assessment tool was used. Finally, we examined the relation between the use of the GRADE approach, systematic review process, and type of funder. Of the 50 guidelines, 17 (34%) systematically synthesised the evidence to inform recommendations. These 17 guidelines clearly reported their objectives and eligibility criteria, conducted comprehensive search strategies, and assessed the quality of the studies. Of the 29/ 50 guidelines that included reviews, 6 (21%) assessed the risk of bias of the review. The quality of primary studies was reported in 30/50 (60%) guidelines.
Indian Journal of Medical Ethics, Oct 28, 2022
Age and Ageing, May 5, 2016
Objectives: to measure sex differences in the risk of receiving potentially inappropriate prescri... more Objectives: to measure sex differences in the risk of receiving potentially inappropriate prescription drugs and to examine what are the factors that contribute to these differences. Design: a retrospective cohort study. Setting: community setting of British Columbia, Canada. Participants: residents of British Columbia aged 65 and older (n = 660,679). Measurements: we measured 2013 period prevalence of prescription dispensations satisfying the American Geriatrics Society's 2012 version of the Beers Criteria for potentially inappropriate medication use in older adults. We used logistic regressions to test for associations between this outcome and a number of clinical and socioeconomic factors. Results: a larger share of women (31%) than of men (26%) filled one or more potentially inappropriate prescription in the community. The odds of receiving potentially inappropriate prescriptions are associated with several clinical and socioeconomic factors. After controlling for those factors, community-dwelling women were at 16% higher odds of receiving a potentially inappropriate prescription than men (adjusted odds ratio = 1.16, 95% confidence interval = 1.12-1.21). Much of this sex difference stemmed from women's increased odds of receiving potentially inappropriate prescriptions for benzodiazepines and other hypnotics, for tertiary tricyclic antidepressants and for non-selective NSAIDs. Conclusion: there are significant sex differences in older adults' risk of receiving a potentially inappropriate prescription as a result of complex intersections between gender and other social constructs. Appropriate responses will therefore require changes in the information, norms and expectations of both prescribers and patients.
Canadian Medical Association Journal, Jun 8, 2004
HAL (Le Centre pour la Communication Scientifique Directe), Apr 6, 2019
Background. There are 32 teaching hospitals in France, including 30 University hospitals and 2 Re... more Background. There are 32 teaching hospitals in France, including 30 University hospitals and 2 Regional teaching hospitals. Teaching hospitals have three roles: health care provision, training of healthcare professionals, and medical research. These roles lead to frequent interactions with pharmaceutical and medical device companies, inevitably raising major risks of conflicts of interests. Therefore, policies to manage conflict of interests (COI) are crucial. This study aims to examine COI policies in French teaching hospitals. . Methods. All French teaching hospitals (n=32) were included in this study. All hospitals websites were screened for institutional COI policies and curriculum on COI, using standardized keyword searches. More data were collected through a questionnaire addressed to each chief executive officer (CEO) of the teaching hospital. We used predefined criteria (n= 20) inspired by similar surveys on COI policies in French, US and Canadian medical schools, with some additions to reflect the local hospital context. A global score for each hospital, ranging from 0 to 58 (higher scores denoting stronger policies) was calculated by summing points obtained for each criterion. Results. Three out of 32 (9%) CEOs replied to the questionnaire. All 32 hospitals had websites; 16 hospitals listed policies or regulations on their websites or provided them on request. In December 2017, among the 32 hospitals, we found that 17 (53.1%) had rules and regulations for some items only, 4 (12.5%) have considered implementing a policy, two of which (6.3%) have begun implementation. and 15 (46.9%) had no evidence of COI policies and a null score. The maximum global score was 24 out of 58, with a mean of 3.50 ± 5.72. . This is the first systematic assessment of COI policies in teaching hospitals in France. Such policies are needed to protect patients, clinicians and students from undue commercial influence. Despite public and political pressure for better management of COI since France's benfluorex (Mediator) scandal of 2010, few teaching hospitals have implemented comprehensive and protective policies. We hope that periodic ranking of hospitals will contribute to raise awareness of the importance of COI policy and speed introduction.
BMJ Open
ObjectivesTo determine the feasibility of a patient-education booklet to support patients with lo... more ObjectivesTo determine the feasibility of a patient-education booklet to support patients with low back pain (LBP) to reduce paracetamol intake.DesignSingle group, repeated measures feasibility study.SettingCommunity.ParticipantsAdults experiencing LBP of any kind and self-reporting consumption of paracetamol for LBP weekly for at least 1 month were invited to participate.InterventionParticipants received a patient-education booklet 1 week after the baseline measures were collected. The intervention was designed to change beliefs, increase knowledge and self-efficacy to deprescribe paracetamol for their LBP and create discussion with a health professional through the mechanisms of motivation, capacity and opportunity.Primary outcome measuresFeasibility of recruitment procedures, data collection and acceptability of the intervention.Secondary outcome measuresChanges in motivation, self-efficacy, opportunity to deprescribe paracetamol for their LBP, paracetamol usage and LBP clinical ...
Indian Journal of Medical Ethics, 2022
Canadian Medical Association Journal, Feb 17, 2004
Drug use in pregnancy has a legacy in regulatory history globally, including in Canada. The two b... more Drug use in pregnancy has a legacy in regulatory history globally, including in Canada. The two bestknown examples are thalidomide,and DES (diethylstilboestrol). Thalidomide was approved for morning sickness in Canada in 1959 and removed from the market in 1962, when it was found to cause severe malformations in exposed babies, including limb reductions. DES (diethylstilbestrol) was prescribed to prevent miscarriage for close to three decades until it was banned for use in pregnancy in 1971 when it was found to cause cancer in women who had been exposed prenatally. The experience with thalidomide led to the introduction of modern drug regulation, with systematic evidence of effectiveness and safety needed before a medicine could be marketed. DES brought home the need for longer-term follow-up of drug safety because unexpected longer-term effects could occur, including cancer 20 years or more after exposure.
International Journal of Clinical Trials, 2021
Background: Prescription and over the counter medications, such as paracetamol, account for a sig... more Background: Prescription and over the counter medications, such as paracetamol, account for a significant proportion of the direct and indirect costs in managing low back pain (LBP). Existing research has not only questioned the efficacy of paracetamol use for musculoskeletal conditions such as LBP, but also its safety. No previous study has investigated the feasibility of a pharmacological education tool for individuals using paracetamol to manage their LBP. The aims of this study are to investigate: (1) the acceptability and experience of participants with the pharmacological education tool, (2) feasibility of recruitment, data collection and outcome measure completion, and (3) participant’s willingness to participate in a randomised control trial.Methods: This will be a single group repeated measures study design recruiting individuals from community organisations. Included participants will be over 18 years, experiencing acute, chronic or recurrent episodes of LBP and self-repor...
BMC Medical Education, 2020
Background Interactions between pharmaceutical and medical device industries and students can lea... more Background Interactions between pharmaceutical and medical device industries and students can lead to commercial influences on educational messages, with a potential to bias future treatment choice. This is the first study in the Baltic countries describing exposure and attitudes of medical, pharmacy and nursing students towards cooperation with industry. Methods A cross-sectional on-line survey of current medical, pharmacy and nursing students (n = 918) in three Baltic countries was carried out. Results We found that most students participate in events organized or sponsored by industry and accept a range of gifts and benefits. Students in the Baltic countries consider cooperation with industry important; at the same time, most do not feel that they have sufficient training on how to ethically interact with pharmaceutical and medical device companies and believe that these interactions can influence their prescribing or dispensing patterns. There is a tendency to rationalize cooper...
BMJ Evidence-Based Medicine, 2019
BackgroundIn November 2017, the Food and Drug Administration (FDA) approved a version of a second... more BackgroundIn November 2017, the Food and Drug Administration (FDA) approved a version of a second-generation antipsychotic, aripiprazole, embedded with a sensor (Abilify MyCite).ObjectiveTo systematically review the evidence supporting the FDA’s approval of digital aripiprazole and how that evidence was disseminated in the scientific literature and news reports.Study selectionProspective, double-blind, randomised controlled trials (RCTs), non-randomised and non-comparative studies were included if they focused on the use of digital aripiprazole. All scientific publications citing the trials were included if written in English. For the news reports, all languages were included if an English translation was available, and all records that were published after FDA approval were included.FindingsIn the primary evidence search, no RCT comparing digital aripiprazole with a non-digital formulation, other active comparators or placebo was found. Only three non-comparative uncontrolled cohor...
International journal of health policy and management, Mar 14, 2018
Relationships between health professionals and pharmaceutical manufacturers can unduly influence ... more Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements and their implementation. The situation differs substantially from country to country and the most striking differences are between government...
PLOS ONE, 2017
Medical faculties have a role in ensuring that their students are protected from undue commercial... more Medical faculties have a role in ensuring that their students are protected from undue commercial influence during their training, and are educated about professional-industry interactions. In North America, many medical faculties have introduced more stringent conflict of interest (COI) policies during the last decade. We asked whether similar steps had been taken in France. We hypothesized that such policies may have been introduced following a 2009-2010 drug safety scandal (benfluorex, Mediator) in which COIs in medicine received prominent press attention. We searched the websites of all 37 French Faculties of Medicine in May 2015 for COI policies and curriculum, using standardized keyword searches. We also surveyed all deans of medicine on institutional COI policies and curriculum, based on criteria developed in similar US and Canadian surveys. Personal contacts were also consulted. We calculated a summary score per faculty based on 13 criteria. [range 0-26; higher scores denoting stronger policies] In total, we found that 9/37 (24%) of French medical schools had either introduced related curriculum or implemented a COI-related policy. Of these, only 1 (2.5%) had restrictive policies for any category. No official COI policies were found at any of the schools. However, at 2 (5%), informal policies were reported. The maximum score per faculty was 5/26, with 28 (76%) scoring 0. This is the first survey in France to examine COI policies at medical faculties. We found little evidence that protection of medical students from undue commercial influence is a priority, either through institutional policies or education. This is despite national transparency
JAMA Internal Medicine, 2016
disease has remained relatively stable from 2009 through 2014, although the prevalence of individ... more disease has remained relatively stable from 2009 through 2014, although the prevalence of individuals reporting adherence to a gluten-free diet has more than tripled (0.52% in 2009-2010 to 1.69% in 2013-2014). Part of what may be driving this gluten-free diet trend is simply a belief, fueled by marketing and media, that these foods are healthier. However, surveys suggest that many individuals who adhere to a gluten-free diet believe that the exclusion of gluten has resulted in subjective health benefits from weight loss to reduced symptoms of inflammation and gastrointestinal distress. Because a gluten-free diet may have negative social, financial, and health repercussions, it is important for clinicians to understand whether, in most cases, it is the elimination of the protein gluten that is responsible for symptom improvement or whether following a gluten-free diet is simply a marker of other dietary choices that are creating positive effects. Not all research has found that individuals who adhered to a gluten-free diet resulted in subjective health benefits. A recent 2-year prospective study 6 from Italy suggests that something other than gluten itself is resulting in self-reported health benefits. Researchers enrolled all consecutive patients with gluten-related symptoms, and after those with celiac disease or wheat allergy were eliminated, only 7.5% experienced any change of symptoms with a gluten-free diet. Studies such as this raise the question of what other than gluten might explain the symptomatic improvement experienced among those following a gluten-free diet. One explanation is that it is not the gluten but the grain itself. Researchers in Australia found that that the fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) and insoluble fiber that are found in glutencontaining foods may be responsible. FODMAPS and insoluble fiber increase the osmotic pressure in the large intestine and promote bacterial fermentation, which results in gas production and abdominal bloat. In a controlled, crossover study 7 of patients with irritable bowel syndrome, a diet low in FODMAPs effectively reduced these symptoms; in a related study, 8 patients who improved while following a low-FODMAP diet experienced no exacerbation of symptoms when gluten was introduced. Another explanation is that gluten elimination may accompany other dietary trends that are associated with improved symptoms. For example, adherents to the popular Paleolithic and autoimmune protocol diets might also report being on a gluten-free diet. 9 There is a debate about whether these diets, which promote eating unprocessed foods that were available in preagricultural times while avoiding grains, oils, and legumes, offer any health advantage over other whole food diets (such as the Mediterranean diet). Nonetheless, some have argued that simply eliminating highly processed foods (including highly processed gluten-containing foods) might result in an improved sense of well-being. Following a gluten-free diet likely means different things to different people, and a heterogeneous group of individuals are adhering to this dietary trend. Although the choice to be gluten free may be driven in part by marketing and a misperception that gluten free is healthier, it is important that this choice not be dismissed as an unfounded trend except for those with celiac dis-ease and wheat allergy. Instead, researchers and clinicians can use this as an opportunity to understand how factors associated with this diet affect a variety of symptoms, including gastrointestinal function, cognition, and overall well-being.
Age and ageing, Jan 5, 2016
to measure sex differences in the risk of receiving potentially inappropriate prescription drugs ... more to measure sex differences in the risk of receiving potentially inappropriate prescription drugs and to examine what are the factors that contribute to these differences. a retrospective cohort study. community setting of British Columbia, Canada. residents of British Columbia aged 65 and older (n = 660,679). we measured 2013 period prevalence of prescription dispensations satisfying the American Geriatrics Society's 2012 version of the Beers Criteria for potentially inappropriate medication use in older adults. We used logistic regressions to test for associations between this outcome and a number of clinical and socioeconomic factors. a larger share of women (31%) than of men (26%) filled one or more potentially inappropriate prescription in the community. The odds of receiving potentially inappropriate prescriptions are associated with several clinical and socioeconomic factors. After controlling for those factors, community-dwelling women were at 16% higher odds of receiving...
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Papers by Barbara Mintzes