Conflicts of interest in submissions and testimonies to an Australian parliamentary inquiry on menopause

Abstract

Conflicts of interest (COIs) have the potential to create bias in research, policy and practice. Although disclosure cannot fully protect individuals and public policy from vested interests, it is an important step to support trust in scientific and public discourse, and transparency in decision-making. However, COIs are often unreported, underreported or difficult to identify. This study aimed to assess the extent to which COIs are voluntarily declared by those who make submissions to government inquiries relating to health, focusing on the 2024 Australian Senate inquiry into perimenopause and menopause. There was no guidance or formal requirement to provide COI declarations in written submissions to the inquiry. However, a statement about COI declarations was given by the Chair of the inquiry at the start of public hearings in which verbal testimony was given. All 284 written submissions and 163 verbal testimonies were reviewed to identify the number and nature of COIs declared. Only 1% of written submissions and 6% of verbal testimonies provided a COI statement. The amount and nature of information provided in COI declarations varied widely. To ensure transparency in decisions made as a result of public inquiries, governments should require that COIs be declared for all submissions. An explicit standardized guide is needed, with clear parameters about the type of detail needed for these declarations. Processes for dealing with COIs should also be clear in any reports or recommendations that are made from the evidence presented at such inquiries.

Contribution to Health Promotion.

• Government inquiries are an important way of collecting evidence and opinions from stakeholders about important health and social issues.

• There is inconsistency in expectations about how conflicts of interest (COIs) are reported and managed in such inquiries.

• We documented the extent and nature of COI statements voluntarily provided to an Australian parliamentary inquiry into menopause.

• Very few individuals and/or organizations provided a statement outlining any COI in their submissions or testimonies.

• Governments should develop standard guidelines about declarations of COIs, and document processes for dealing with these in any reports from public inquiries.

BACKGROUND

A conflict of interest (COI) is a ‘set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest’ (Lo and Field, 2009). The impact and influence of COIs on research, policy and practice has continued to be a focus in public health and clinical research (Romain, 2015; Stead, 2017; Resnik, 2023). As McCoy and Emanuel (2017) highlight, consideration of how COIs are reported is important because the information provided in COI declarations reveals any potential risk of bias and resulting harm. Studies have shown that, in particular, commercial COIs create the potential for bias. For example, a systematic literature review conducted by Lundh et al. (2017) found that drug and device studies sponsored by industry were more likely to produce results showing greater favourable efficacy and conclusions than for studies sponsored by other sources, and ‘the existence of an industry bias that cannot be explained by the standard “Risk of bias” assessment’. Similarly, a review conducted by Nejstgaard et al. (2020) found financial COIs to be associated with favourable drug and device recommendations in clinical guidelines, narrative reviews, opinion pieces and advisory committee reports.

While there is substantial and clear evidence about the impact of COIs on research, policy and practice (Nejstgaard et al., 2020), researchers have argued that COIs remain ‘underreported, inconsistently described, and difficult to access’ (Dunn et al., 2016). Furthermore, while disclosures of COIs have been described as a minimum expectation in alerting individuals to potential bias (McKinney and Pierce, 2017), the disclosure of COIs does not take the potential conflict or impact of the conflict away. Researchers have investigated the extent and nature of COI reporting in academic research (Baram et al., 2022); the challenges relating to disclosures (Ruff, 2015); and how COIs may compromise the design of research and reporting of results (Lundh et al., 2017). Researchers have also expressed concerns that COIs can impact the evidence that is collected in systematic reviews which are often used to guide health guidelines, policy and practice, as well as public opinion about an issue (Dunn et al., 2016). A recent study found peer reviewers and editors rarely commented on study funding and COIs (or declared their own COIs) (Makarem et al., 2023). Vested interests can also encourage over-diagnosis and treatment and lead to the medicalization of what are, in fact, normal human experiences (Moynihan et al., 2013).

While most research has focused on the reporting of COIs in academic research, much less research has focused on COI declarations in other settings—including where health information may be communicated, or where evidence or guidance may be presented with the aim of influencing health and social policy. Researchers investigating these contexts have found that while health professionals, stakeholders and researchers may have significant COIs, these are not always transparent (Taheri et al., 2021; Flood et al., 2022). For example, a study investigating COIs and funding sources in health communications on social media platforms found that a significant proportion of healthcare professionals using social media have financial relationships with industry (up to 80%), that most of these relationships are not reported, and that there is evidence of potential associations between COIs and the content of the posts (Helou et al., 2023). COIs are also a contributing factor to bias in guideline development (Parker and Bero, 2022). A recent analysis of members of the United States 2020 Dietary Guidelines Advisory Committee found that 95% of members had COIs with the food and/or pharmaceutical industries (Mialon et al., 2024). Given the potential impact of COIs on guidelines and health policy decisions, there is still a gap in understanding the nature, extent and expectations of COI declarations in any activity that may have an influence on health policy and decision-making.

Experience from public consultations highlights the importance of considering COI in consultations on public policy. Lin et al. (2017) assessed submissions from 158 organizations to a consultation on draft US Center for Disease Control (CDC) opioid prescribing guidelines, including whether the organizations had received financing from opioid manufacturers. The latter was assessed based on tax records, annual reports and organizational websites, as the CDC had not required COI disclosures. Organizations without any pharmaceutical industry financing were more often fully supportive of the CDC guideline recommendations (54.7%) especially compared with those with funding from opioid manufacturers (6.7%). These draft guidelines recommended limits on opioid prescribed doses and durations, with the aim of supporting patient safety, and within the context of a US epidemic of opioid-related mortality and serious morbidity fuelled by overprescribing (Makary et al., 2017).

One area of women’s health for which COIs are particularly relevant at present is menopause—the point in time 12 months after a woman’s last menstrual period (World Health Organization, 2022). In recent years, perimenopause and menopause have become increasing topics of public discussion, media interest and policy attention (McCartney, 2022; Burgin et al., 2024; Thomas et al., 2024). Researchers have argued that the framing of messages around menopause are influenced by several powerful groups and industries, including commercial entities who stand to financially benefit from menopause (Krajewski, 2019; Thomas et al., 2024). In 2023, the value of the global commercial menopause market size was estimated to be US$16.9 billion, and by 2030 is estimated to grow to US$24.4 billion (Grand View Research Inc., 2023). This includes not only menopausal hormonal treatments but also dietary and alternative supplements. In addition, there is a growing market of commercial organizations that offer consultancies and accreditations that claim to make workplaces more ‘menopause-friendly’ [e.g. (Menopause Friendly Australia, 2024)]. These include personal coaching and mental health services that purport to help women successfully navigate their work and careers during menopause [e.g. (Transitioning Well, 2024)]. There is an increasing lens on how commercial interests may ‘catastrophise’ menopause as a strategy to stimulate and drive (arguably unnecessary) product purchases (Burgin et al., 2024), the impacts of ‘menopause influencers’ (Lewis, 2023), and ‘menowashing’ strategies that reinforce harmful tropes and gendered ideologies, particularly relating to ageing (Bettany, 2024). Commercial interests stand to benefit significantly from a broadened definition of ‘menopause’. The promotion of a wide range of services and treatments may claim to enable women to navigate this stage of their lives more effectively but may actually prey on women for profit (Burgin et al., 2024).

Significant concerns have also been raised about COIs in menopause policy-making processes, particularly related to the influence of the pharmaceutical industry. This has included concerns related to a recent United Kingdom (UK) All Party Parliamentary Group into menopause, with a British Medical Journal commentary cautioning about the potential for vested interests to shape the inquiry:

‘Sometimes high profile campaigns are useful to put unseen conditions on the agenda, but we must always ask who is setting the terms and conditions and what the biases might be’ (McCartney, 2022).

These concerns are important given that women’s health issues may be vulnerable to commercial capture (McCarthy et al., 2023)—including how industries co-opt feminist narratives to promote non-evidence–based health interventions (Copp et al., 2024) and commercialize women’s health concerns (Mishra et al., 2023).

In the Australian context, there has been scant attention paid to potential COIs in menopause research and policy recommendations, but there are indications that it deserves increased attention. For example, a 2023–2024 Pre-Budget Submission about menopause to the Australian Federal Government, co-authored by a range of senior academics, media personalities, health professionals, business owners and representatives from health associations  stated that the document was: ‘facilitated with funding support from Besins Healthcare Australia, however the content is independent of Besins Healthcare, and contributors did not receive any funding’ [(Wellfemme Women’s Health Services, 2023), p. 10]. Besins Healthcare describes itself as: ‘… a family-run company with a laser focus on hormone treatments for conditions including menopause, fertility and testosterone deficiency’ (Besins Healthcare, 2024).

In 2024, the Australian federal government launched a Senate Inquiry into the health and economic impacts of perimenopause and menopause on women, and the impacts on the economy more broadly (hereafter referred to as the Australian Senate Inquiry) (Commonwealth of Australia, 2024). The official report from the Inquiry ‘Issues related to menopause and perimenopause’ was released in September 2024 (Community Affairs References Committee, 2024). The purpose of the Australian Senate Inquiry was to gather evidence from women, health professionals, employers, researchers and other experts and to make recommendations regarding what funding and policies were required to effectively support women during perimenopause and menopause. While this new policy interest in menopause is important, it is vital—particularly given the concerns about COIs that were raised regarding the UK All Party Parliamentary Group into menopause (McCartney, 2022)—that there is complete transparency in any COIs and that these are taken into consideration in any policy decisions and recommendations that are made about menopause.

The following study aimed to understand the extent to which COIs were voluntarily declared by the organizations and individuals who provided written submissions and/or verbal testimonies to the Australian Senate Inquiry. The study was guided by two research questions:

1. To what extent are COIs voluntarily disclosed in submissions to an Australian government inquiry into menopause?

2. What was the nature and extent of any COIs disclosed?

METHOD

Overview and process relating to COI declarations

The terms of reference for the inquiry were posted on the Parliament of Australia website (Parliament of Australia, 2024b) and focused on a broad range of issues related to menopause and perimenopause, including economic consequences (including workforce issues); physical health impacts and access to health services; mental and emotional wellbeing; impacts on caregiving, family dynamics and relationships; cultural and societal issues—including issues specifically impacting culturally and linguistically diverse communities and First Nations women; level of awareness in a range of stakeholders including health professionals and employers; existing government policies, programs and initiatives; and how other jurisdictions provide support from a health and workplace policy perspective.

Written submissions to the Inquiry were invited through the official parliamentary website until 15 March 2024. Following this, public hearings were held in six locations across Australia over 7 days (17 June–6 August 2024). Written submissions were made public on the parliamentary website, as were the Hansard transcripts of the public hearings, the responses to questions taken on notice during the public hearings, and other documents tabled to the Inquiry (Parliament of Australia, 2024a).

There were some differences in the expectations about declarations of COIs for written submissions and verbal testimonies during the Inquiry. While the Inquiry’s Terms of Reference did not include any instructions regarding the declaration of COIs for written submissions, at the start of each day of public hearings where invited verbal testimonies were given, the Committee Chair gave the following instructions to those present at the time:

‘Real and perceived conflicts of interest can negatively affect public confidence in the integrity of inquiries. As such, the committee encourages all witnesses participating in the hearing today to declare to the committee any matters, whether of pecuniary or other interest, where there may be, or may be perceived to be, a possible conflict of interest’ (Commonwealth, 2024).

The Committee Chair did not repeat this statement throughout the day of public hearings, and individual witnesses were not directly asked if they had any interests to declare prior to them giving testimony.

Data collection

The following documents which were publicly available on the Inquiry’s formal parliamentary website (Parliament of Australia, 2024a) were downloaded for review (29 August 2024):

• All written submissions—from 284 organizations and individuals.

• Transcripts of all seven days of public hearings held by the Committee in Sydney (17 June 2024), Melbourne (18 June 2024), Brisbane (29 July 2024), Canberra (30 July and 13 August 2024), Adelaide (5 August 2024) and Perth (6 August 2024), which included testimony from 163 witnesses.

• All 20 documents providing responses to questions taken on notice during witness testimonies.

Analysis

Details of the submissions were tabulated using Microsoft Excel, and a descriptive content analysis was used to summarize the characteristics of the sample. Each submission was classified in terms of the type of submitter—submissions were assigned to one of the following classifications: commercial (commercial organizations or associations, groups and individuals with commercial interests, including for-profit businesses which focused on menopause); health organizations (organizations representing public health interests including peak bodies); clinicians (individuals whose submissions represent the perspective of someone who treats patients as their primary occupation); academics (academic institutions, research centres or groups or individual researchers); individuals (submissions from individuals in a personal capacity, including those with lived experience); health insurance companies; trade unions; superannuation companies; other groups (including organizations from non-health sectors); and confidential (written submissions that were not made publicly available). In some cases, the individual submissions could have been assigned to more than one classification, for example where the person was an academic researcher at a university and also practiced as a clinician. In these cases, the individual was subjectively classified according to the dominant substance of their submission. For example, if the submission was from an academic who specifically stated they were providing a submission in an individual capacity they were classified as ‘individual’, and if a health centre was part of a university they were classified as ‘academic’.

Submissions were also coded according to whether a COI statement was provided for the submitter/s (yes/no); whether a COI was disclosed (yes/none) and the nature of any interest disclosed (financial/non-financial, or both). Where a COI statement was provided, the information was analysed in terms of the nature of interest disclosed and the level of detail provided (for example, the type and value of any financial interests, the length of time a conflicting arrangement had been in place and so on).

Most of the organizations and individuals who made written and verbal submissions provided general information about themselves and the context in which they were making the submission (for example, details about their expertise and the type of work they do, or their own personal experience). For the purposes of this paper, this type of information was not considered to be a COI declaration because it was provided as general background information for the committee rather than for the purposes of disclosing interests, and was generally unrelated to any financial relationship. In addition, some of the submissions included supplementary or additional documents such as published journal articles which included a COI statement as was required by the journal submission guidelines. In this case, the Inquiry submission was considered not to have included a COI statement because the COI information was not included in the main submission, only as part of the supporting documentation.

RESULTS

Written submissions

Of the 284 written submissions, the largest proportion 126 (44%) were from individuals. For some of these submissions, only a first name was given (46, 17%), and some were marked as name withheld (64, 23%). Following this, 50 (18%) were from health organizations, 29 (10%) were from entities with commercial interests, 13 (5%) were from trade unions, 12 (4%) were from academics and 8 were from clinicians (3%). The remaining submissions were from government entities (5, 2%), superannuation companies (3, 1%), health insurance companies (3, 1%) and other organizations (19, 7%). Sixteen submissions (6%) were confidential submissions and not available to the public, so they have been excluded from our analysis.

Only 3 of the 284 written submissions (1%) included a COI disclosure statement for the organizational or individual author, and all three were submissions from health organizations. Supplementary File 1 contains details of submissions and whether a COI disclosure statement was provided or not.

The first COI statement was included in the submission from the Monash Centre for Health Research and Implementation (Monash Centre for Health Research and Implementation, 2024). It disclosed financial interests of one of the authors who was a clinician researcher and member of the Centre. Declared interests included travel funds and speaker honoraria from biotechnology and pharmaceutical companies, consulting fees from pharmaceutical companies and research funding from several Australian government research funding agencies. The second COI statement was from Jean Hailes for Women’s Health (Jean Hailes for Women’s Health, 2024). The statement disclosed partnerships with commercial entities since Jean Hailes was established and provided a definition for the term ‘commercial entities’. It also disclosed the acceptance of sponsorships from commercial entities (these were not named) and explained how the sponsorship funds were used by the organization. The statement clarified that the two primary authors of the submission had no interests to declare. The third COI statement was from the Australian Menopause Society, the peak body (or representative non-governmental organization) for women’s health in midlife and menopause (Australian Menopause Society, 2024). The statement disclosed partnerships with commercial entities (these were not named) and provided a definition for this term, and sponsorships from commercial entities and described how the sponsorship funds were used by the organization. The statement did not provide a disclosure statement for the individual authors of the submission document.

Public hearings

Verbal testimonies were provided by 163 individuals over the 7 days of public hearings. Of these, 45 (28%) were representing health organizations, 29 (18%) were linked to entities with commercial interests, 28 (17%) were from individuals (of these 24, 15% provided first names only), 16 (10%) were academics and 16 (10%) were representing trade unions. The remaining submissions were from individuals representing governments (6, 4%), superannuation companies (3, 2%), clinicians (2, 1%) and other organizations (18, 11%). Of the 163 witnesses who provided testimony, 10 individuals (6%) provided statements related to COIs. While not part of formal declarations of interest, two witnesses commented on their relationship (or lack thereof) with the pharmaceutical industry. Professor Helena Teede from the Monash Centre for Health Research at Monash University stated that her Centre did not take any funding from the pharmaceutical industry for educational programs for general practitioners, and Dr Louise Newson from Newson Health stated that, unlike many menopause specialists, she did not work with any pharmaceutical companies.

Two of the individuals who provided COI statements as part of their verbal testimony represented two of the organizations that had also provided COI statements in their written submissions. The first was Dr Sarah White, CEO of Jean Hailes for Women’s Health. Dr White verbally re-stated COIs for both the organization and individually to the Committee at the hearing, including a broad statement that the organization received funding from government to produce health information and education in relation to menopause and timeframes for when this funding was received. The COI statement also included receiving funding from for-profit organizations related to menopause to deliver health information and professional education. For the witness personally, COIs included attending a roundtable organized by a pharmaceutical company (not named) and accepting funding for travel from a for-profit company (not named) to give a presentation (including the amount that was accepted). Dr White also disclosed a non-financial personal COI—membership of the Australasian Menopause Society. The second witness Dr Amanda Vincent, representing the Monash Centre for Health Research and Implementation, stated that their conflicts were disclosed in their submission but did not restate these conflicts as part of their verbal testimony.

Three witnesses who did not provide COI statements in their original written submissions provided a statement during their testimony. Professor Danielle Mazza, a general practice clinical researcher representing SPHERE Centre of Research Excellence at Monash University which focuses on women’s sexual and reproductive health, declared that they had received funding for research and advisory committee membership from two pharmaceutical companies - Bayer and Organon. Dr Kelly Teagle, general practitioner and founder of a national menopause clinic Wellfemme, declared a financial COI—stating that they had accepted funding from private industry (with no specific company name provided) and a non-financial COI—membership of the Australian Menopause Society. The third COI statement was from Associate Professor Erin Morton (Chief Investigator and Lead, Virtual Perimenopause Registry of Australia—with no academic affiliation stated), a researcher in clinical trials and health data who disclosed non-financial interests, including unpaid consultancies in academic committee roles and in advisory capacities, as well as providing an estimated number of research projects they had conducted while working in the academic, government and non-profit sectors, and gave a timeframe for this work. They also disclosed that they had their own research consultancy (Bespoke Clinical Research) and that they had no active contracts in conflict with their testimony.

Professor Martha Hickey, a professor of obstetrics and gynaecology at the University of Melbourne and a clinical psychologist, explained that she was an NHMRC fellow in menopause and funded by the Medical Research Future Fund (MRFF) for research on the prevention of early menopause and why some women suffer severe symptoms of menopause. Professor Hickey also stated that she did not take any funding from industry for her research or in any other capacity. Finally, four witnesses—two academic researchers Professor Gita Mishra from SPHERE Centre for Research Excellence at Monash University and Professor Helena Teede from the Monash Centre for Health Research at Monash University, Mrs Caroline Mulcahy, Chair of the Family Planning Alliance of Australia and one individual (Janey)—stated that they had no interests to declare.

DISCUSSION

This study highlights the inadequate transparency about COIs in the Australian Senate Inquiry on menopause. Few written submissions contained any COI declaration (n = 3, 1%), and there were diverse types of information provided in these COI statements. It is important to acknowledge the individuals and organizations who voluntarily provided COI information to the Inquiry. They should be recognized for their efforts to do so, particularly given there was limited formal guidance from the Inquiry. Although the Inquiry Chair requested that witnesses declare their COIs at the start of each day of public hearings, the large majority of those who provided verbal testimony did not disclose any interests including verbally testifying that they had no interests to declare. Additionally, the Chair’s instructions for witnesses to declare their COIs were not repeated throughout the day and provided no guidance on what they should declare or what time period declarations should cover. It is unclear whether those who provided verbal testimony had been advised by the Inquiry secretariat prior to the public hearings that they should provide this information at the start of their testimony. However, it is reasonable to assume that many of those who provided testimony would not have been present at the start of the day of public hearings, and as such may not have heard the information about COIs that was provided by the Chair.

The Inquiry report contained 25 important recommendations for women's health and wellbeing, including strengthening the evidence base about the impacts of (peri)menopause on Australian women, co-designing evidence-based public education campaigns and including (peri)menopause in medical curricula. However, there were also recommendations that have potential commercial implications (Community Affairs References Committee, 2024). These included those relating to pharmaceutical supply chains and pricing trends, and ensuring that ‘MHT items are affordable and accessible, including consideration of domestic manufacturing and alternate means of subsidising costs to the consumer’ (p. xv). This suggests an alternate means of public reimbursement of pharmaceuticals that bypasses the Pharmaceutical Benefits Scheme (PBS) assessment of cost effectiveness, which is based not only on the price of a treatment but also a rigorous review of the evidence on effectiveness and safety as compared with available alternatives. There were also recommendations related to the implementation of menopause policies in the workplace, including that ‘Australian workplaces develop perimenopause and menopause workplace policies in consultation with their employees’ (p. xiv). During the Inquiry, concerns were raised about commercial organizations offering ‘menopause friendly’ workplace accreditation, and the evidence base for these activities (May, 2024). Given the potential commercial implications of the Inquiry's policy recommendations, it is concerning that there was no discussion in the report about if or how the Inquiry considered COIs in developing their recommendations.

Australia does not have legislated requirements for companies to disclose their payments to health professionals, such as the U.S. Physician Payment Sunshine Act (Department of Health and Human Services, 2013). Companies that are members of Medicines Australia, the trade association representing the brand-name pharmaceutical industry, are required to report certain types of payments, including consultancies and travel or conference expenses, but not research funding or food and drink (Medicines Australia, 2022). The latter (funding for research and food/drinks) is the most common type of funding companies provide to health professionals. Although incomplete because not all companies or payment types are included, this does go some way to making financial arrangements public. Companies also report payments to health consumer groups, but these reports are made company by company and are not consolidated into a centralized searchable database.

Government inquiries and public consultations are a mechanism for collecting evidence-based input into legislative processes. Because of this, governments must have clear processes which require and guide those who engage with inquiries to provide statements about COIs. Such inquiries could draw upon principles of research integrity in developing clear and accessible guidance for those who wish to submit to Inquiries. For example, in the case of Australia, the Australian Code for the Responsible Conduct of Research (NHMRC et al., 2018a) provides a set of Principles for all research conducted under the auspices of Australian institutions. Principle 3—transparency—requires that actual, potential and perceived COIs be disclosed and managed during the research process, with guidelines on how conflicts should be disclosed and managed to ensure responsible research conduct (NHMRC et al., 2018b). The International Committee of Medical Journal Editors also has clear guidelines for declarations of COIs including disclosure forms which ask for information about any funding support for research, grants or contracts from any entity, royalties or licenses, consulting fees, payments or honoraria, payment for expert testimony, support for attending meetings or travel, patents, participation on boards or advisory boards, leadership or fiduciary roles, stock or stock options, receipt of equipment, materials, gifts or other services and any other financial or non-financial interests (ICMJE, 2021). The above Principles and established templates could be adapted to develop guidance for those submitting to Parliamentary inquiries. It is important that this guidance is clear and accessible and should not create a barrier to submission—particularly for the general public or those with lived experience. It is also important for government inquiries to be clear and transparent about how they considered COIs in developing their recommendations and findings. Novel forms of communication (including short videos) could be placed on inquiry websites to guide individuals about the importance of COI declarations and short online forms could be created to document any COIs before a submission is uploaded. Limited research has investigated whether educational initiatives improve declarations of interest, and the framing, delivery and impact of these types of initiatives will be important to evaluate moving forward.

While some may question whether individuals with lived experience should be required to submit COIs, there is evidence to suggest that this is important. Researchers have shown that they are able to predict the messages in testimony that are given by patients who have links to vested interests. For example, Holman and Geislar (2018) carried out a grounded theory analysis of patient testimony at a U.S. Food and Drug Administration (FDA) patient consultation on female sexual dysfunction. All of the women testifying described common core experiences of lack of sexual desire and resulting relationship difficulties. Messages on causes and solutions differed between those with and without industry affiliations. Those with industry affiliations described their experiences within a biological framework of their bodies letting them down and this being a ‘severe medical condition… and no amount of talk therapy is going to fix it’ (p. 874). In contrast, those without industry affiliations discussed relationship problems and unrealistic cultural expectations as contributing to sexual difficulties, and psychotherapy and better communication with partners as solutions. However, the present study also demonstrates how important it is for inquiries to thoroughly consider the potential impact of COIs on the evidence that may be presented. Although these individuals declared COIs, the FDA’s report did not analyse links between the content of testimony and COI, and most participants were industry-funded. This led to a very different message about patient priorities than had COI been taken into account (Holman and Geislar, 2018). Pharmaceutical and medical device industry funding of medical research and patient health advocacy is widespread, and this funding is often closely linked to companies’ commercial priorities. Gentilini and Parvanova analysed the payments that 74 pharmaceutical companies made to UK patient groups in 2020 and found that 90% of the funds went to groups representing conditions aligned with companies’ product portfolios or pipelines (Gentilini and Parvanova, 2023). This share was even higher—97%—when restricted to disease-specific patient groups.

These examples demonstrate the importance of ensuring that all individuals should be provided with clear guidance about COIs, and are supported to provide these. They also highlight that it is important that those responsible for developing policies are transparent about how COIs are considered when making decisions about public policy. These processes should be clearly documented in any reports that are published. This is particularly important given concerns about the large commercial market opportunities relating to menopause—not only from the pharmaceutical industry but also from private clinics and from the wellness industry—and the vulnerability of women’s health issues to corporate capture.

LIMITATIONS

This study had a number of limitations. First, our classification of different individuals, groups and organizations was subjective based on the evidence provided in submissions to the Inquiry. Sometimes this was not completely clear (there were times when individuals submitted to the Inquiry more than once, in different capacities and with different titles). Guidelines and templates could help to ensure clarity around these affiliations. We were also not able to conclusively determine if people who had their name withheld were women with a lived experience of menopause. There were a number of confidential submissions—but it was not clear why these were confidential, and whether there were any COIs related to these submissions. Finally, the aim of this paper was to examine the extent and nature of voluntary COI declarations to an Australian Senate Inquiry, not to fact-check the accuracy of COI declarations. For this reason, we do not make any comment regarding the accuracy of the COIs disclosed or not disclosed, but acknowledge that this is a separate but important avenue for future research.

CONCLUSION

There is an urgent need to protect women’s health from vested interests, and this includes systematic processes to ensure transparency in COIs. This is especially important in relation to financial COIs, which have been shown to be influential in medical research, clinical guideline development and policy consultations. However, we would note that while transparency is important, simply declaring a COI does not take the conflict away and as McCartney argues, ‘transparency as a means to conquer conflicts of interest is illusory’ (McCartney, 2024). In relation to parliamentary inquiries, governments should set clear parameters for declaring COIs, especially where submissions are made from a wide range of entities including organizations, professionals and lay people who may have varying levels of knowledge regarding what constitutes COIs. Guidelines should include clear definitions of the information that should be provided, what needs to be disclosed and what level of detail is required. Where a submitter has no COIs, they should be required to explicitly declare this. For verbal submissions, each witness should be directly asked if they have COIs to declare before they provide testimony. It is also important for this information to be publicly available. The responsibility for educating submitters about expectations regarding COIs lies with the government. As this study shows, in the absence of clear guidance on how and why COIs should be disclosed, submitters may omit to declare. Education and careful instruction are essential to ensure transparency in the information considered when making important policy decisions that affect women’s health.

ETHICAL APPROVAL

N/A. This paper reviewed publicly available documents on a parliamentary website.

DATA AVAILABILITY

The documents reviewed in this paper are publicly available on the Parliament of Australia Issues related to menopause and perimenopause website.