‘What price do you put on your health?’: Medical cannabis, financial toxicity and patient perspectives on medication access in advanced cancer
OLSON et al.
School of Social Science University of Queensland St Lucia Queensland Australia
Mater Health Services, Mater Research Institute University of Queensland Brisbane Queensland Australia
Palliative Care St Vincent's Private Hospital Brisbane Brisbane Queensland Australia
School of Medicine University of Queensland Herston Queensland Australia
* Correspondence Rebecca E. Olson, PhD, Associate Professor, School of Social Science, University of Queensland, St Lucia, Qld, Australia.Email: r.olson@uq.edu.au
Abstract
Introduction
Following 2016 legislation permitting limited access to cannabis for research and medicinal purposes, the number of randomized clinical trials (RCTs) investigating the effectiveness of medicinal cannabis (MC) on symptom burden relief in cancer contexts has increased in Australia. This study aimed to understand the perceptions, hopes and concerns of people with advanced cancer regarding the future availability and regulation of MC in Australia.
Methods
This qualitative study draws on semistructured interviews conducted between February 2019 and October 2020 in Brisbane, Australia, as part of an MC RCT substudy. Interviews were undertaken on 48 patients with advanced cancer in palliative care eligible to participate in an MC trial (n = 26 participated in an RCT; n = 2 participated in a pilot study; n = 20 declined). Interviews included a discussion of patients' decision‐making regarding trial participation, concerns about MC and perceptions of future availability, including cost. Transcribed interviews were analysed inductively and abductively, informed by constructivist thematic analysis conventions.
Results
Overall, participants supported making MC legally accessible as a prescription‐only medication. Fear of financial toxicity, however, compromised this pathway. Steep posttrial costs of accessing MC prompted several people to decline trial participation, and others to predict—if found effective—that many would either access MC through alternative pathways or reduce their prescribed dosage to enable affordable access.
Conclusions
These findings suggest that—despite a relatively robust universal healthcare system—Australians are potentially vulnerable to and fearful of financial toxicity. Prevalent in the United States, financial toxicity occurs when disadvantaged cancer patients access necessary but expensive medications with lasting consequences: bankruptcy, ongoing anxiety and cancer worry. Interview transcripts indicate that financial fears—and the systems sustaining them—may pose a threat to RCT completion and to equitable access to legal MC. Such findings support calls for embedding qualitative substudies and community partnerships within RCTs, while also suggesting the importance of subsidisation to overcoming injustices.
Patient or Public Contribution
A patient advisory committee informed RCT design. This qualitative substudy foregrounds patients' decision‐making, perceptions and experiences.
Article notes
Olson RE , Smith A , Good P , Dudley M , Gurgenci T , Hardy J . ‘What price do you put on your health?’: medical cannabis, financial toxicity and patient perspectives on medication access in advanced cancer. Health Expect. 2023;26:160‐171. 10.1111/hex.13642 PMC985431336335552
1INTRODUCTION
Patients with advanced cancer face numerous symptom burdens: pain, fatigue, nausea and sleep disturbance. 1 Following 2016 legislation permitting limited access to cannabis for research and medicinal purposes in Australia, 2 interest in the potential benefits of medicinal cannabis (MC) as an intervention for relief from symptom burden associated with cancer and advanced cancer has increased substantially. 3 , 4 , 5 Several clinical trials have subsequently been initiated. 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 Data from trials, especially randomized controlled trials, however, can be ‘difficult to transfer to real‐life experiences’. 14 While randomized clinical trials (RCTs) examine the effectiveness of MC at controlling symptom burden based on an experimental design, little is known about the experiences and concerns of Australians with advanced cancer considering MC.
Understanding patients' concerns, particularly related to access and regulation, is complicated by the history of cannabis as a recreational drug, and the funding, healthcare and regulatory practices specific to each country. Recreational cannabis (RC)—involving smoking or ingesting the cannabis plant which contains over 500 compounds—has been a prohibited substance for most of the 20th century. 15 Recently, cannabis has been progressively remedicalized as a viable treatment for a range of illnesses, conditions and symptoms, 16 typically involving the specific chemical compounds cannabinol (CBD) and tetrahydrocannabinol (THC) in isolation or combination. 17 This remedicalization has occurred on a global scale, with legitimate channels for accessing MC now established in North America, South America, Europe, Israel and Australia. 18 How receptive countries have been to MC, however, varies. Jamaica's legal therapeutic cannabis market, for example, faces diplomatic and marketing challenges, with constraints imposed by agreements with the United Nations and the United States and purchasers conflating RC and MC. 19 Stigma has also been found to be a barrier to accessing MC in the United States, 20 and a contributor to perceptions and experiences of MC use in Thailand 21 , 22 , 23 and Canada, 24 but does not feature as such in the limited Australian‐focussed scholarship. 5 , 25
In Australia, MC users face two tiers of regulation. Cannabis policy is split between federal and state jurisdictions, with federal policy progressing slowly, and states devising their own approaches. 26 Despite 2016 legislation changes allowing limited access to MC via prescription from strictly regulated healthcare specialists, survey research suggests Australians still access cannabis through illicit channels and hold concerns about financial and administrative barriers to accessing MC within existing regulatory frameworks. 27 This research suggests that 62.6% of Australians assessed MC as prohibitively expensive, and 87.3% found the existing regulatory framework difficult to negotiate. 27 The number of Australians accessing MC has progressively increased, with a total of 159,665 approvals issued by 31 August 2021, 82.4% of which were issued after January 2020. 28
Concerns about access must be contextualized with reference to Australia's healthcare system: a mixed public–private system underpinned by Australia's universal coverage known as Medicare. 29 Under Medicare, costs associated with hospital‐based and some community‐based care (e.g., bulk billing General Practices) are funded through taxation (e.g., Medicare Levy; Medical Levy Surcharge). 30 Australians are, however, incentivized through tax deductions to supplement with private health insurance, 31 and approximately 46% do so, allowing them access to private hospitals and ‘extras’ coverage, including dental, optical, allied health and other services. 29 , 32 Within this system, Australians access prescription medication at a reduced cost as most are included on the government's Pharmaceutical Benefits Scheme (PBS). For patients, this scheme dramatically reduces the price of pharmaceuticals filled through a pharmacist, requiring only modest out‐of‐pocket co‐payments. Such co‐payments are capped at $42.50 AUD for each PBS medicine dispensed and $6.80 AUD for those with concession cards (e.g., pensioners, students), and cumulatively at $1542.10 AUD or $326.80 AUD annually. 33 In this same environment of government‐subsidised medicines, however, authorized MC products cost consumers between $350 and $600 per 100 ml (oil) and around $200 for a 15 ml spray (figures accurate as at August 2022).
1.1Objectives and theoretical framework
Survey research suggests Australians are concerned about MC's financial and administrative burden, 27 but little to no in‐depth research has been conducted with Australians with advanced cancer. This is a unique population with incurable, but often long‐term disease, who are underrepresented in clinical trials and research more generally—and especially so those with poor performance status and/or high symptom burden. 34 , 35 , 36 , 37 This study aims to understand the perceptions, hopes and concerns of people with advanced cancer regarding the future availability and regulation of MC in Australia.
Supporting this objective, we draw on a concept of growing interest in cancer care—financial toxicity—extended by a social constructionist understanding of medication use as situated and agentic. Financial burden has traditionally been understood in terms of the direct financial costs associated with treatment, such as out‐of‐pocket expenses remaining after government subsidy for certain medications, or the costs associated with attending multiple clinicians across several specialist clinics. 38 Financial toxicity represents growing recognition of the need to broaden conceptualizations of financial burden to account for indirect costs such as the associated emotional burden and the coping strategies patients employ. 38 , 39
Financial toxicity occurs when cancer patients—especially those with early and more severe disease—pay out‐of‐pocket costs (including travel and accommodation) to access necessary but expensive interventions, often while experiencing income loss due to reduced hours or early retirement, with lasting consequences to their finances and mental health, including debt, bankruptcy, emotional well‐being (distress, anxiety and worry about a recurrence), quality of life and survival. 39 , 40 , 41 , 42 Unsurprisingly, financial toxicity is more common in countries where healthcare is predominantly privately funded; 53.7% of cancer patients surveyed in the United States reported experiencing financial toxicity. 39 It is less prevalent in Australia, with research suggesting its commonality to be near 7% for Australians 12 months postdiagnosis with colorectal cancer, compared to 39% for patients with colorectal cancer in Ireland, 40 and 20% for Australian men with prostate cancer. 43
Although financial toxicity represents a broader conceptualization of financial burden, with terms like ‘cost‐related nonadherence’ used to describe strategies of coping with financial toxicity, 39 the concept can be critiqued as furthering a clinician‐centred understanding of financial burden. Thus, we expand our conceptual framework, drawing on Conrad's 44 classic medical sociology concept of ‘medication practice’, helping us to shift our focus towards a patient‐centred understanding of MC's financial and regulatory availability for Australians with advanced cancer. Medication practice can be defined as, ‘how people manage their medications, focusing on the meaning and use of medications’ and viewing ‘patients as active agents rather than passive recipients of doctors' orders’. 44 Taking such an approach allowed us to prioritize a patient‐centred examination of concerns and hopes regarding MC's future availability, to inform justice‐oriented 45 RCT study design and policy.
2METHODS
2.1Study design and recruitment
This qualitative substudy examined the perceptions of people with advanced cancer eligible to participate in an MC trial. 25 Semistructured interviews were arranged with recognition of the time and communication needs of people with advanced cancer, taking a pace set by the interviewee to accommodate for any fatigue. Compared to surveys, interviews allowed for the collection of richer, inductive findings into subjective experiences and concerns about MC's future availability. 46 An experienced qualitative researcher oversaw data collection, with interviews facilitated in Brisbane, Australia, between February 2019 and October 2020. The substudy was approved by Human Research Ethics Committees at two hospitals: the Mater Hospital (HREC/17/MHS/97) and St Vincent's Hospital (HREC 17/27).
To participate in interviews, participants had to be eligible to consent to one of three MC trials conducted by the research team; the protocols for the two RCTs and results for the pilot study have been published. 6 , 7 , 8 Relevant eligibility criteria for these MC trials included the following: (a) having an advanced (incurable) histology‐proven cancer diagnosis as defined by its anatomical components as locally advanced or metastatic; (b) receiving palliative care at the treating hospital; (c) experiencing symptom burden; (d) being aged 25 or older. 6 , 7 , 8 MC was sourced through a registered MC manufacturer and made available to those participating in an MC trial through a hospital pharmacy, dispensed as an oil. 6 , 7 , 8 Recruitment for interviewees, led by the clinical trials coordinator, co‐occurred with RCT recruitment. Purposive sampling enabled balanced representation across the two interviewee groups—those who declined and those who consented to MC trial participation—and in terms of gender and age (see Table 1).
| Characteristic | Interview participants | ||
|---|---|---|---|
| Trial participant (n = 28) | Declined trial participation (n = 20) | Total (n = 48) | |
| Gender, n (%) | |||
| Male | 12 (25) | 11 (22.91) | 23 (47.91) |
| Female | 16 (33.33) | 9 (18.75) | 25 (52.08) |
| Age in years, n (%) | |||
| ≤49 | 3 (6.25) | 3 (6.25) | |
| 50–69 | 15 (31.25) | 9 (20.8) | 24 (50) |
| 70–89 | 10 (20.83) | 11 (22.91) | 21 (43.75) |
| Marital status, n (%) | |||
| Married/civil partnership | 23 (47.91) | 11 (22.91) | 34 (70.83) |
| Divorced/separated/widowed | 5 (10.42) | 8 (16.66) | 13 (27.08) |
| Single | 1 (2.08) | 1 (2.08) | |
| Ethnicity, n (%) | |||
| Anglo‐Saxon/English | 17 (35.41) | 18 (37.5) | 35 (72.92) |
| Australian | 3 (6.25) | 3 (6.25) | |
| Pacific Islander | 3 (6.25) | 3 (6.35) | |
| Australasian | 1 (2.08) | 1 (2.08) | |
| Scottish | 1 (2.08) | 1 (2.08) | |
| Undisclosed | 3 (6.25) | 2 (4.16) | 5 (10.41) |
| Education level, n (%) | |||
| Did not complete high school | 3 (6.25) | 3 (6.25) | |
| High school | 24 (50) | 16 (33.33) | 40 (83.33) |
| Bachelor's degree | 1 (2.08) | 1 (2.08) | |
| Unknown | 1 (2.08) | 3 (6.25) | 4 (8.33) |
| Primary cancer diagnosis, n (%) | |||
| Breast | 6 (12.5) | 6 (12.5) | 12 (25) |
| Prostate | 3 (6.25) | 7 (14.58) | 10 (20.83) |
| Lung | 4 (8.33) | 3 (6.25) | 7 (14.58) |
| Ovarian | 3 (6.25) | 3 (6.25) | |
| Endometrial | 3 (6.25) | 3 (6.25) | |
| Urothelial | 2 (4.16) | 2 (4.16) | |
| Pancreatic | 2 (4.16) | 2 (4.16) | |
| Colorectal/rectal | 2 (4.16) | 2 (4.16) | |
| Bladder | 1 (2.08) | 1 (2.08) | |
| Bile duct | 1 (2.08) | 1 (2.08) | |
| Gastrooesophageal | 1 (2.08) | 1 (2.08) | |
| Glioma | 1 (2.08) | 1 (2.08) | |
| Kidney | 1 (2.08) | 1 (2.08) | |
| Mesothelioma | 1 (2.08) | 1 (2.08) | |
| Unknown primary | 1 (2.08) | 1 (2.08) | |
2.2Data collection
Interviews lasted between 20 and 60 min, facilitated by one of two experienced interviewees with backgrounds in sociology and social work. Most interviews (n = 42) were face‐to‐face, held within a hospital consultation room in a quiet area of the hospital. Following public health measures related to COVID‐19, interviewees were given the option—in accordance with an approved ethics amendment—to participate via telephone. Six interviews were subsequently conducted via telephone. Using an interview guide, facilitators prompted participants to reflect on their perspectives on MC and research, their main reasons for participating or not participating in a trial, their perceptions on current and changing MC laws and their opinions on future access. Following an iterative approach to data collection, data generated in earlier interviews refined the focus of the interviews 47 ; themes identified in initial analysis informed revisions to the semistructured interview guide. For example, in considering transcripts from initial interviews, several participants described financial barriers, prompting us to add a question about financial concerns to the interview guide. All interviews were audio‐recorded, with each interviewee being assigned a numerical pseudonym following verbatim transcription.
2.3Data analysis
Data analysis was guided by constructivist approaches to thematic analysis. 48 , 49 , 50 Grounded theory informed elements of the study design, such as taking an iterative approach to data collection and analysis. 47 However, in line with the epistemological positioning and appreciation of knowledge as co‐constructed 51 that underpins constructivist thematic analysis, the research team's reflexive and theory‐informed positioning was foregrounded (rather than bracketed) to prioritize inductive and abductive analysis.
Transcripts were analysed thematically and by case, using NVivo 12 qualitative analysis software to support data management, and to create and organize codes based on the research aims, interview questions and evolving findings. Open coding was undertaken to identify new themes and facilitate comparison. Regular meetings across the team of qualitative researchers and RCT study leads in the early stages of data collection, supported our discussion of findings from selected transcripts. Such meetings prompted us to attend to our differing positions in engaging with transcripts and foreground multiplicity in our theory‐informed interpretations, as we come from disciplinary backgrounds in sociology, medicine, social science, social work and anthropology. Following the discussion in our meeting on findings related to cost, themes were mapped against scholarship on financial toxicity, 39 and extended by Conrad's 44 concept of medication practice. Informed by these discussions, two members of the research team progressed data analysis and code development.
3RESULTS
A total of 48 people with advanced cancer were recruited: 26 who agreed to participate in an RCT, 2 who agreed to participate in a pilot study and 20 who declined RCT or pilot study participation (see Table 1). Participants were relatively evenly divided in terms of gender (52% female) and age (50% aged 50–69).
Several themes were produced through our analysis(see Figure 1). This section first presents themes on patients' perceptions of how MC should be made accessible in the future, with most supportive of restricting access to a prescription‐only medication, dispensed by a pharmacist. We then provide patients' perceptions on current barriers—financial and administrative—to this accessibility, with many expressing concern about the high cost of accessing MC and predicting access outside of pharmacies to manage these costs.
Themes are supported by data displays from patient interviewees, including reference to their participant number (e.g., ‘P5’ for participant 5), gender (e.g., ‘F’ for female), age (e.g., 70s) and trial participation status (e.g., ‘declined’ indicates they did not participate in an MC trial; ‘Pilot‐CBD’ indicates participation on the MC Pilot study 7 receiving the CBD intervention). Information is provided as to which RCT arms participants were assigned (e.g., MC1‐CBD refers to the intervention arm of the MC1 study 6 ; MC1‐Placebo refers to the control group). It is also noted when this information is not yet available (e.g., MC2‐Blinded refers to participation on the MC2 study, 8 where information on control and intervention group assignment remains blinded). Where participants described sourcing cannabis for medicinal purposes outside of the trial, this is indicated (e.g., Non‐trial MC).
3.1Future access: Who and how
Interviewees were supportive of making MC accessible, to ‘people who need it’ (P26, F, 50s, MC2‐Blinded) and who were ‘going to be responsible’ in using it (P38, F, 70s, Non‐trial MC). One interviewee went so far as to suggest a screening process:[J]ust as long as … people that actually need it are screened properly and have all the documentation necessary to actually go on it. Because we see too many people who don't really need it, access it and then they screw it up for the rest of us. (P25, F, 30s, MC2‐Blinded)
Although a minority said ‘it should be open to everyone and anyone’ (P14, F, 40s, MC1‐CBD), other participants specified that it should be available to populations where other interventions have been shown to be less effective, such as chronic pain and cancer care (P21, F, 30s, MC1‐CBD), terminal illness (P18, M, 60s, MC1‐CBD) and conditions such as Parkinson's disease:[It should be made available for] I suppose mainly—there are a lot of cancer sufferers. For anyone really that's suffering, with people that [have] Motor Neurone Disease, if it helps them. People that have multiple sclerosis, if it helps them. Parkinson's, all of these really challenging diseases. If it helps those people, then I believe that they should be able to have access to it. (P23, F, 70s, MC1‐Placebo)
In discussing how MC should be made available, one interviewee saw too much regulation as problematic: ‘I don't think it should be controlled by state or federal government. I think it's something that they don't need to be involved in’ (P18, M, 60s, MC1‐CBD). Others (P26, F, 50s, MC2‐Blinded; P29, M, 60s, Non‐trial MC) suggested RC should be decriminalized and MC made available at pharmacies.[I think it should be available] freely, over the counter. Yeah … I think it should be decriminalised. There shouldn't be criminal convictions and all the rest because you've got a bit of pot in your pocket. (P29, M, 60s, Non‐trial MC)
Most, however, responded by referencing existing mechanisms for regulating, supplying and dispensing medicines in the Australian context. Participants concluded that availability should be ‘controlled’ (P14, F, 40s, MC1‐CBD; P37, M, 66, declined), to prevent MC from being ‘abused’ (P33, F, 70s, declined) and out of a concern for safety (P13, F, 70s, MC1‐Placebo).If I can't get it on a prescription I wouldn't be having it, no way, no. So, it's got to be something that you've got to get…. through chemists, through your doctor and you must have to have a script for it at all times. (P15, M, 70s, MC1‐Placebo)
Accordingly, several participants proposed limiting access to those with a prescription made by a specialist (P13, F, 75, MC1‐Placebo) or General Practitioner (P12, M, 60s, MC1‐Placebo; P22, M, 70s, MC1‐Placebo; P33, F, 70s, declined; P18, M, 60s, MC1‐CBD).Just from your doctor and the same as any other medicine is dispensed … A prescription, yes. I don't think you could just walk in and buy it. It would still have to be controlled. (P37, M, 60s, declined)
Even those participants with a history of sourcing MC through alternative pathways, and who decried the challenges of accessing MC for others, talked about controlling the supply of MC to mitigate perceived abuse:You've got to put some controls on it otherwise you'll get abuse…. if you just say, ‘oh you're feeling depressed and so you can get an [unclear]’, well 98 per cent of Australia would be depressed in the morning … it would need to be controlled, there's no doubt about it … possibly the same way as you have the prescription medication. (P30, M, 60s, Non‐trial MC)
Overall, most participants saw benefits to limiting access to MC to individuals with a diagnosed condition and a medical prescription, ordered by a physician and dispensed by a pharmacist. Financial and administrative challenges, however, were said to pose barriers to achieving the perceived safety and hoped‐for equity of regulated access to MC.
4DISCUSSION
This qualitative study aimed to understand the perceptions, hopes and concerns of people with advanced cancer regarding the future availability and regulation of MC in Australia. Overall findings suggest that patients are supportive of making MC legally accessible as a prescription‐only medication. Fear of the financial risks, however, compromised this pathway. The administrative ‘speed bumps’ and steep posttrial cost of accessing MC prompted several people to decline trial participation, and others to predict—if found effective—that many would either reduce their prescribed dosage to enable affordable legal access, or access MC through alternative pathways. Below, we discuss this contribution, theorizing the financial risks of accessing MC posttrial as financial toxicity, and explicating the threat it poses to equitable access to legal MC and RCT participation. We then consider the implications of this finding for policy and RCT design, suggesting subsidisation and qualitative substudies as ways of foregrounding and overcoming possible injustices.
Interviewees were overwhelmingly supportive of making MC legally accessible as a prescription‐only medication. As 28 of our interviewees were individuals with advanced cancer consenting to participate in trials—a hypermedicalized context involving a high degree of medical control, including, in these trials, restricting eligibility to those with no cannabis in their system—this sample may seem to be providing a relatively skewed perspective. However, other Australian research examining broader public perceptions of MC use suggests that these patients/participants are not outliers—acceptability of MC is high amongst the general population 27 , 52 and a majority of general practitioners are also supportive or neutral on MC use. 53 Furthermore, it is important to note that patients were screened for RCT eligibility after consenting to participate. Thus, some interviewees who consented to participate in an MC RCT and interview, may have been found to be ineligible later because of having cannabis in their system. Despite support for it, MC was also perceived as a current or potential source of financial toxicity by patients with advanced cancer interviewed for this study—amongst those who consented MC RCT participation and those declined—with five participants directly citing cost in their decision to not participate in an MC RCT. Said another way, MC was perceived by many as a necessary or potentially necessary intervention, with associated costs that could prompt financial strain. 39 Many reflected on the posttrial cost of accessing MC, using emotional and disparaging language to express their fear and concern. This finding supports research from the United Kingdom 54 and Canada 55 showing significant financial barriers to accessibility for patients, despite MC being available in these countries within regulatory frameworks. However, it may be surprising in the Australian context, given that financial toxicity is less prevalent in this country, 40 especially compared to countries with limited public healthcare systems, such as the United States. 39 This finding may also be surprising considering financial toxicity is often associated with an early‐stage diagnosis. 40 Nonetheless, financial toxicity was a concern for interviewees with advanced cancer in this study. Many interviewees were facing chronic symptom burden and were pensioners, with few classified as high socioeconomic status: all factors which have been found to be significant predictors of a financial burden and financial toxicity. 38 , 56
In responding to their financial toxicity concerns, interviewees described several mitigation strategies: stretching, shifting and declining. Some participants predicted ‘stretching’ their supply to better weather MC's posttrial financial imposition, taking less than the recommended dose to reduce their weekly MC expenditure. This is a well‐known strategy for coping with financial toxicity, referred to as ‘cost‐related medical nonadherence’ 39 or ‘cost‐related medication underuse’ 57 within medical scholarship and, less pejoratively, active or agentic ‘medication practices’ within sociological scholarship. 44
Shifting—to alternative markets—was another financial toxicity coping strategy, but less acknowledged within cancer scholarship and potentially unique to MC. Despite overwhelming support for restricting access to a pharmacy prescription, interviewees described unreservedly sourcing MC via less than legal pathways. Blurring or hybridizing RC and MC, some predicted or actively engaged in abandoning concerns related to safety and control, and sourcing uncompounded cannabis online or via a trusted supplier for a fraction of the cost and without the administrative burden. This finding suggests that pragmatism in the Australian context may override the stigma related to accessing MC found in research from the United States. 20 It also supports research by Mahamad and Hammond 55 pointing to the continued existence, and indeed flourishing, of ‘black market’ sources of medicinally used cannabis in environments of legalized, regulated MC. Within the context of financial toxicity, 39 this study draws attention to the ‘coping’ practice of sourcing medication illegally to treat their conditions—a practice suggested to be widespread but below the ‘public gaze’. 15 Sociologically, this practice is referred to as engaging in ‘covert’ or ‘subaltern’ therapeutics: using interventions deemed outside of medicine, resistant to biomedicine (such as ‘folk medicine’), or, in the case of marijuana, criminalized. 15 For policy, this finding raises important questions about state processes with poor streamlining, potentially posing a threat to MC schemes, 19 and certainly motivating potential MC users' consideration of less legal competitors.
In addition to stretching and shifting, declining was a further strategy for mitigating MC's perceived financial toxicity. Five interviewees declined to participate in an MC trial citing cost as a reason. Despite MC being available at no cost to trial participants, the high posttrial cost prompted these interviewees to circumnavigate financial concerns by avoiding MC altogether. 25 This barrier to MC RCT participation raises important concerns about equitable access to tested interventions, and the potential impact of these concerns on patient decision‐making regarding trial participation. In her research on disparities in RCT participation, Fisher 58 shows marginalized men overrepresented in early‐stage pharmaceutical testing, but underrepresented as intervention users. Our study suggests economically disadvantaged participants may be deterred from participating. Such inequities could undermine RCT completion, as well as impact fair and equitable access to tested interventions following trial completion. While recruitment was not an issue for the MC trials supported by this qualitative substudy, it is a common problem. An estimated 50% of RCTs fail to recruit to their targets, 59 a problem amplified within palliative care contexts, where sample attrition is a regular and expected occurrence. 60
Qualitative substudies—as illustrated through this study—and community partnerships can foreground inequities that threaten to undermine RCT recruitment. Fortuna et al. 45 suggest countering the reductionism that underpins the scientific method—epitomized by RCTs—with humanistic approaches—such as qualitative and participatory methods—that ‘prioritize[] the human experience and promote[] the inclusion of disadvantaged populations as partners in research’. As evidenced in this study, ‘methodological pluralism’ 45 —through a qualitative substudy—can allowed researchers to identify differences in power and resources that could undermine clinical research and clinical outcomes.
While small revisions to study designs and research practice can go some way towards attending to inequities, broader change is also needed. Findings presented here suggest that without subsidisation (e.g., through the PBS), MC poses substantial risks: risk of financial toxicity to patients and their families, and potentially to equitable access to the benefits of RCT participation. Although demonstrated effectiveness is a requirement for pharmaceutical interventions to be listed on the PBS, MC poses a unique scenario where patients are accessing similar interventions covertly through alternative or subaltern therapeutic pathways. There is thus an imperative for commercial entities involved in MC to invest in and support clinical trials to produce high‐quality evidence of efficacy and safety, to ensure quality and to embed equity of future access through registration and subsidisation via the PBS.
The strengths of our study included drawing insights from both those who consented, and those who declined, to participate in an MC trial. An iterative and abductive approach 48 , 49 , 50 , 51 also foregrounded patients' concerns and critical insights from the study's conceptual framework. The cross‐sectional approach, however, limited data to a single timepoint; the exclusive focus on patients' decision‐making overshadowed carers' perceptions. Future research will further give insights into perceptions and experiences, by purposively sampling patients and carer participants at different trial stages.
5CONCLUSION
The findings and analysis presented here provide novel insights into the perceptions, hopes and concerns of people with advanced cancer regarding the future availability and regulation of MC in Australia. Findings suggest patients are aware and fearful of financial toxicity related to the high cost of accessing MC outside of clinical trials. To improve affordability, equity of access for patients and equity in MC's treatment as a pharmaceutical intervention—interviewees supported making MC a prescription‐only medication subsided by Australia's PBS. Qualitative substudies are valued additions to RCTs—shining light on injustices relevant to RCT recruitment and design, but in this context, policy and practice change may be needed to overcome MC's financial toxicity. Put simply, many interviewees assessed legally available MC to be of little use without ensuring commensurate affordability. Future research could examine the prevalence of concerns in Australia related to MC's financial toxicity and establish the commonality of subaltern or covert use of RC/MC.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
ETHICS STATEMENT
Ethical approval for this study was obtained from the Human Research Ethics Committees at the Mater Hospital (HREC/17/MHS/97) and St Vincent's Hospital (HREC 17/27). All participants provided their written informed consent.
ACKNOWLEDGEMENTS
The authors wish to thank the TalkingMedCan participants for their time and insights. We are grateful for the research support provided by Thomas Dinala, Karyn Foster, Georgie Huggett and Zhaoxi Zheng. Funding for this study was provided by a National Health and Medical Research Council (NHMRC) of Australia Medical Research Future Fund (MRFF) Grant (APP1140160, 2018–2022) and a Mater Clinical Research Seeding Grant (2017‐2019). None of these funders had a role in the study design, collection, analysis or interpretation of the data, writing the manuscript or the decision to submit the paper for publication.
DATA AVAILABILITY STATEMENT
Data generated and analysed for the current study are available to suitably qualified individuals by request, from the corresponding author, subject to HREC approval.