Latest news with #Prometrium
The Age
09-07-2025
- Health
- The Age
One hormone was a game-changer for Andrea's perimenopause. She wants other women to have access, too
They have signed a petition to the Pharmaceutical Benefits Advisory Committee and the federal government, stating: 'There are currently nine PBS-listed treatments for men's sexual health, and ZERO listed for women.' 'Men's sexual health is routinely subsidised. But women have to fight for theirs — or fund it themselves.' Petition to the Pharmaceutical Benefits Advisory Committee and the government 'Men's sexual health is routinely subsidised. But women have to fight for theirs — or fund it themselves. That's not healthcare. That's a double standard,' states the petition, which was launched in June by Dr Ceri Cashell, a New South Wales GP. Cashell said: 'Every week, women tell me that testosterone was really helping, but they had to give it up because it's just too expensive. And that is not right. 'I used to hear this all the time about Prometrium (body-identical progesterone). And having Prometrium listed on the PBS has been a life-saver for many of my patients, sometimes literally, because of its profound effects on sleep.' In her submission to the Senate's inquiry into issues relating to menopause, Cashell called for three body-identical hormones: estradiol, micronised progesterone, and testosterone 'to be accessible and affordable for Australian women who need to use them'. Because only the first two are PBS-listed, and testosterone treatment for hypoactive sexual desire disorder is so expensive, Griffith University steroid-use researcher Dr Tim Piotkowski says women are obtaining testosterone intended for men and attempting to measure suitable amounts, risking side effects. 'Women are not being afforded access to things that men are,' Piotkowski said. 'These women often feel overlooked by traditional healthcare and unsupported when they seek help.' Collins put it like this: 'Women are suffering, and our sex lives are so important for our health … it's a healthy part of our lives, having that connection and intimacy with someone.' When that desire is absent, 'you just don't want to have anyone near you at that stage'. Endocrinologist, Professor Susan Davis, a spokeswoman for the Australasian Menopause Society and long-term researcher at Monash University, agrees testosterone treatment should be subsidised, but only on authority script to prevent it being prescribed for menopause symptoms other than hypoactive sexual desire disorder. Debate and discussion about the perceived wider benefits of testosterone for women has raged among menopause advocates, and publicity on social media has caused a big spike in demand. But Davis, a former president of the International Menopause Society, said there was only evidence of its effectiveness for hypoactive sexual desire disorder. Some claims made about testosterone's other potential benefits for midlife women were 'overselling the need and the benefit'. Testosterone supplementation at midlife has been promoted as being able to improve women's low mood, concentration, memory and sleep problems. It has also been said to protect women's bones, muscles and brains. Such claims were unproven, and 'making women feel they are missing out if they are not on it', Davis saids. She noted that there was only one medication for male erectile dysfunction on the PBS, and it was available only on authority script. Davis' team has studies under way examining how testosterone treatments effect women's muscles and bones, but she said that in claims already being made about its benefits: 'The language is quite emotive, and raises a red flag.' 'The guideline is this can increase the number of sexually satisfying events [for the woman] by one per month, which is not a lot.' Professor Martha Hickey, Melbourne University and Royal Women's Hospital, Melbourne 'There is no evidence for [those benefits] at this point.' A paper Davis helped write was used by the petition authors to source the statistic that one-third of Australian women experience hypoactive sexual desire disorder, but she now considers that data to be 'a rough estimate', and said an imminent paper would suggest the accurate proportion is 'about half of that'. The clinical benefit of AndroFeme 1 for women experiencing low sex drive had been shown to be modest, said Professor Martha Hickey, chair of obstetrics and gynaecology at Melbourne University. Loading 'The guideline is this can increase the number of sexually satisfying events [for the woman] by one per month, which is not a lot,' she said. 'Depending on what you're starting from, it is not that much. And this drug has only been shown to be effective in that specific condition.' Hickey also disputed the accuracy of the figure of one in three women experiencing hypoactive sexual desire disorder, as distinct from low libido, in midlife: 'And low libido is not what this is for. The other thing is there's no safety data available on AndoFeme 1 use beyond 12 weeks. 'It's a hormone, and hormones have powerful effects in many organs of the body,' Hickey said. Evidence did not support the suggestion that testosterone dropped significantly at menopause, like oestrogen has been shown to, contrary to what has been suggested by some of its proponents online. 'I'm very suspicious of the commercial forces that are driving this,' Hickey said. But women's health psychiatrist Professor Jayashri Kulkani, director of Monash University's HER Centre Australia and of the Multidisciplinary Alfred Psychiatry research centre, says subsidising testosterone therapy for women goes beyond its proven benefits for low libido. 'It [testosterone] is the third hormone for all of the menopause-related issues that many women experience, including mental ill-health,' she said. 'The petition and advocating group have picked HSDD because they think there is more evidence for AndroFeme in treating this issue but in actual fact, it is a hormone treatment that is part of menopausal hormone therapy for all of the symptoms that many (but not all) women experience in the menopause transition.' Kulkarni said that women should have access to PBS-subsidised testosterone for reasons beyond sexual dysfunction. Loading 'The bigger picture here is menopausal mental ill-health [depression, anxiety, brain fog] is the really big issue,' she said. 'So I agree with the petition to get AndroFeme 1 on the PBS but for the bigger cause, not just HSDD.' A spokesperson for the Department of Health and Aged Care said the government and the Pharmaceutical Benefits Advisory Committee would welcome applications to list AndroFeme1 or similar testosterone products on the PBS.
Sydney Morning Herald
09-07-2025
- Health
- Sydney Morning Herald
One hormone was a game-changer for Andrea's perimenopause. She wants other women to have access, too
They have signed a petition to the Pharmaceutical Benefits Advisory Committee and the federal government, stating: 'There are currently nine PBS-listed treatments for men's sexual health, and ZERO listed for women.' 'Men's sexual health is routinely subsidised. But women have to fight for theirs — or fund it themselves.' Petition to the Pharmaceutical Benefits Advisory Committee and the government 'Men's sexual health is routinely subsidised. But women have to fight for theirs — or fund it themselves. That's not healthcare. That's a double standard,' states the petition, which was launched in June by Dr Ceri Cashell, a New South Wales GP. Cashell said: 'Every week, women tell me that testosterone was really helping, but they had to give it up because it's just too expensive. And that is not right. 'I used to hear this all the time about Prometrium (body-identical progesterone). And having Prometrium listed on the PBS has been a life-saver for many of my patients, sometimes literally, because of its profound effects on sleep.' In her submission to the Senate's inquiry into issues relating to menopause, Cashell called for three body-identical hormones: estradiol, micronised progesterone, and testosterone 'to be accessible and affordable for Australian women who need to use them'. Because only the first two are PBS-listed, and testosterone treatment for hypoactive sexual desire disorder is so expensive, Griffith University steroid-use researcher Dr Tim Piotkowski says women are obtaining testosterone intended for men and attempting to measure suitable amounts, risking side effects. 'Women are not being afforded access to things that men are,' Piotkowski said. 'These women often feel overlooked by traditional healthcare and unsupported when they seek help.' Collins put it like this: 'Women are suffering, and our sex lives are so important for our health … it's a healthy part of our lives, having that connection and intimacy with someone.' When that desire is absent, 'you just don't want to have anyone near you at that stage'. Endocrinologist, Professor Susan Davis, a spokeswoman for the Australasian Menopause Society and long-term researcher at Monash University, agrees testosterone treatment should be subsidised, but only on authority script to prevent it being prescribed for menopause symptoms other than hypoactive sexual desire disorder. Debate and discussion about the perceived wider benefits of testosterone for women has raged among menopause advocates, and publicity on social media has caused a big spike in demand. But Davis, a former president of the International Menopause Society, said there was only evidence of its effectiveness for hypoactive sexual desire disorder. Some claims made about testosterone's other potential benefits for midlife women were 'overselling the need and the benefit'. Testosterone supplementation at midlife has been promoted as being able to improve women's low mood, concentration, memory and sleep problems. It has also been said to protect women's bones, muscles and brains. Such claims were unproven, and 'making women feel they are missing out if they are not on it', Davis saids. She noted that there was only one medication for male erectile dysfunction on the PBS, and it was available only on authority script. Davis' team has studies under way examining how testosterone treatments effect women's muscles and bones, but she said that in claims already being made about its benefits: 'The language is quite emotive, and raises a red flag.' 'The guideline is this can increase the number of sexually satisfying events [for the woman] by one per month, which is not a lot.' Professor Martha Hickey, Melbourne University and Royal Women's Hospital, Melbourne 'There is no evidence for [those benefits] at this point.' A paper Davis helped write was used by the petition authors to source the statistic that one-third of Australian women experience hypoactive sexual desire disorder, but she now considers that data to be 'a rough estimate', and said an imminent paper would suggest the accurate proportion is 'about half of that'. The clinical benefit of AndroFeme 1 for women experiencing low sex drive had been shown to be modest, said Professor Martha Hickey, chair of obstetrics and gynaecology at Melbourne University. Loading 'The guideline is this can increase the number of sexually satisfying events [for the woman] by one per month, which is not a lot,' she said. 'Depending on what you're starting from, it is not that much. And this drug has only been shown to be effective in that specific condition.' Hickey also disputed the accuracy of the figure of one in three women experiencing hypoactive sexual desire disorder, as distinct from low libido, in midlife: 'And low libido is not what this is for. The other thing is there's no safety data available on AndoFeme 1 use beyond 12 weeks. 'It's a hormone, and hormones have powerful effects in many organs of the body,' Hickey said. Evidence did not support the suggestion that testosterone dropped significantly at menopause, like oestrogen has been shown to, contrary to what has been suggested by some of its proponents online. 'I'm very suspicious of the commercial forces that are driving this,' Hickey said. But women's health psychiatrist Professor Jayashri Kulkani, director of Monash University's HER Centre Australia and of the Multidisciplinary Alfred Psychiatry research centre, says subsidising testosterone therapy for women goes beyond its proven benefits for low libido. 'It [testosterone] is the third hormone for all of the menopause-related issues that many women experience, including mental ill-health,' she said. 'The petition and advocating group have picked HSDD because they think there is more evidence for AndroFeme in treating this issue but in actual fact, it is a hormone treatment that is part of menopausal hormone therapy for all of the symptoms that many (but not all) women experience in the menopause transition.' Kulkarni said that women should have access to PBS-subsidised testosterone for reasons beyond sexual dysfunction. Loading 'The bigger picture here is menopausal mental ill-health [depression, anxiety, brain fog] is the really big issue,' she said. 'So I agree with the petition to get AndroFeme 1 on the PBS but for the bigger cause, not just HSDD.' A spokesperson for the Department of Health and Aged Care said the government and the Pharmaceutical Benefits Advisory Committee would welcome applications to list AndroFeme1 or similar testosterone products on the PBS.
The Guardian
25-02-2025
- Health
- The Guardian
A landmark Australian inquiry put the spotlight on menopause. But was the process transparent?
A landmark Senate inquiry which helped catapult menopause out of the shadows and into mainstream health conversations has been accused of inadequately disclosing ties with pharmaceutical companies and other commercial interests. In a paper published in the journal Public Health International in November, Australian researchers found that despite the chair of the committee inviting disclosures of conflict of interest, only three conflict of interest statements were included in 284 written submissions. Just 10 of the individuals giving evidence in person made verbal disclosures about conflicts of interest. Yet some of those involved in the Senate inquiry – and the lobbying that led up to it – had support from pharmaceutical companies or stood to gain through menopause being given a much higher profile in health policy. It comes as a high-profile conference on menopause treatments being held in Sydney this weekend exposed divisions among some medical practitioners over the dosage of hormone therapies and the efficacy of testosterone as a treatment for menopausal women. The sold-out public conference at the Opera House has not been supported by the Australasian Menopause Society. A second day for medical professionals featuring the same speakers is being sponsored by several pharmaceutical companies, but organisers say there is no involvement of big pharma in the public event. This month the Labor government responded to the Senate inquiry recommendations, putting $573m on the table for women's health – including a new Medicare rebate for menopause health assessments, funding to train health professionals, the first-ever clinical guidelines and a national awareness campaign. It also includes a Pharmaceutical Benefits Scheme (PBS) listing for the new menopausal hormone therapies Prometrium, Estrogel and Estrogel Pro, the first in over 20 years, meaning those therapies can be bought at a government-subsidised price. The move will save women using menopause hormone therapy (MRT) hundreds of dollars a year. But while the additional funding is being welcomed, within some parts of the medical profession there is concern about whether the parliamentary inquiry was used by lobbyists for pharmaceutical interests and others with direct commercial stakes in the industry to advance their business interests – without proper disclosure. 'Yes, it gave voice to women in the community, but it looks like [parliament's] institutions may have been influenced by people with agendas,' said Prof Susan Davis, a leading endocrinologist from Monash University. 'Anyone could have written the shopping list of recommendations without an inquiry. I think it was a response to a lot of lobbying.' A similar debate has erupted in the United Kingdom over support from the pharmaceutical industry for the All Party Parliamentary Group on Menopause that has been advocating for changes to the NHS and better awareness of menopause in the workplace and in government. Disclosures by the committee show that from 2021 until 2023 its secretariat services were provided by Interel Consulting UK and then Dentons Global Advisors. These firms in turn received £185,000 from pharmaceutical companies Theramax, Astellas Pharma, Bayer and Bristol Myers Squibb. Lobbying is a completely legal activity and part of the process of democracy. Sometimes, the interests of consumers – in this case perimenopausal and menopausal women – can align with commercial interests. But it is important for decision makers to know when financial interests could be having an influence. Geoffery Watson, the director of the Centre for Public Integrity, says disclosure is essential for transparency in public inquiries. But he also notes 'that disclosure doesn't make the conflict of interest go away. It clearly still has an effect on the viewpoint being put.' The authors of the Public Health International report also note that disclosure ' … is an important step to support trust in scientific and public discourse, and transparency in decision-making'. One of the key people driving the establishment of the Australian Senate inquiry was Johanna Wicks, a long time health advocate in the not-for-profit sector whose own menopause experience had got her interested in the subject. Through a mutual contact, she was introduced to Besins Healthcare, 'a family-run company with a laser focus on hormone treatments for conditions including menopause, fertility and testosterone deficiency'. It is an international company with a direct presence in 22 countries. Wicks sat down for an extended interview with Sonya Lovell on the Dear Menopause podcast, during which she explained her involvement in the Senate inquiry. Lovell described Wicks as '99% responsible' for the Australian Senate inquiry going ahead. Wicks' first job for Besins was to produce a strategy and to probe why menopause had become such a big issue in the US and the UK, but had stayed in the shadows in Australia. After the May 2022 election, she says she realised that there was a real opportunity to make change: the 47th parliament was filled with women in their 40s and 50s who would have direct experience of the struggles of perimenopause and menopause. Wicks organised a roundtable with the help of Labor MP the late Peta Murphy, followed by a Parliament House event in February 2023 that featured eight speakers, including representatives from the Australasian Menopause Society. Nearly 20 MPs attended. Sign up for Guardian Australia's breaking news email Greens senator Larissa Waters then took up the cause and a Senate inquiry was initiated. A spokesperson for Waters said it was always clear that Wicks was working for Besins, a manufacturer of hormones in Australia. Around this time, a faultline opened between a group of social media-savvy women and doctors sometimes referred to as the 'menoposse' – who are adept at using their considerable online presence to promote menopause as an issue of women's self determination – and doctors, organisations and research bodies who hail from a more sober scientific background. Opening the inquiry, the chairperson, the Greens senator Penny Allman-Payne, noted: Sign up to Breaking News Australia Get the most important news as it breaks after newsletter promotion 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. The interests of medical practitioners who gave evidence were probably obvious. More awareness of menopause and treatments available will probably lead to more patients. Some have thriving practices and online advice sites for women. But other interests were more opaque. For instance, some submitters had businesses that sell consultancy services to companies to help them make their workplaces more menopause friendly. Others had social media businesses that promote the issue. Some of these receive support from pharmaceutical companies for their activities. A large number of women also gave evidence of their personal struggles with perimenopause and menopause and its impact on their mental health and relationships. Witnesses were often passionate about how MRT had changed their lives. Those with menopause businesses often fell into this category as well, having been motivated by their own experience to start websites, podcasts, consultancies and the like. For example, Shelly Horton, who now runs a workplace consultancy, participated in the round table as a woman with lived experience. Wicks insists on the podcast that Besins, her employer, just wanted 'to activate the space' and there was never any discussion about driving sales of their products. 'Let's just say there are some members of the establishment who have done very well out of the fact that menopause has stayed in the shadows, very financially well out of government funding, and they did not like my appearance on the scene,' she told Guardian Australia. She says that some who have criticised the new guard and denigrated them as 'influencers' – with connections to big pharma – have been on the receiving end of millions of dollars in government grants. Wicks was involved in its written submission but parted company with Besins before the hearings in Canberra, where Besins gave evidence. The other faction in the 'menopause wars' are worried about the quality of advice and treatments and the catastrophising of menopause, which could further harm middle-aged women who already face headwinds in the workplace. 'This is a really natural phase of life and pretty much all women will have some symptoms, be they irregular periods, hot flushes and some sleeplessness. And this will coincide with a very complex phase of life, as women are often juggling multiple responsibilities,' said the chair of the Royal Australian College of GPs' specific interest sexual health medicine group, Associate Prof Magdalena Simonis. 'So it's a stage not just where hormones play their part but the social and cultural aspects of where women sit in society also impacts this dramatically.' The Senate inquiry's recommendations were widely welcomed by the pharmaceutical industry. The committee highlighted the need for more research on the experiences of women and other people going through menopause and for more education. It called for national guidelines on treatment and more training for healthcare professionals to provide the right advice and support. It also identified a lack of access to medicines and treatments at affordable prices – mainly menopause hormone therapy. The recent announcement of new PBS listings for hormones will be a major benefit to women. But it will also be a major benefit to Besins, the manufacturer of the three hormone products placed on the PBS. The authors of the paper on conflict of interest say while there are highly developed protocols for declaring financial sponsorship of research, the same is not true in the area of health policy. They pointed to a recent analysis of members of the United States 2020 dietary guidelines advisory committee, which found that 95% of members had potential conflicts of interest with the food or pharmaceutical industries. Another study found that those who made submissions to a US inquiry into opioid use who had connections to doctors were far more likely to oppose more radical interventions to handle the crisis than those without doctor connections. 'We should all disclose what our relationships are with industry,' said Simonis. 'Paying me, sponsoring me, if I had shares in the company then I should disclose it.' 'There are commercial relationships and academic relationships and they should be made transparent.'
