Unveiling Risks to PHARMAC’s Integrity and Women’s Health Amidst Testogel Approval

On February 8 the New Zealand Government announced that its Pharmaceutical Management Agency (PHARMAC) will add testosterone gel to its funded prescription drug scheme (PHARMAC, 2024). Testosterone gel will be funded when prescribed for “any relevant clinical use including for people requiring gender-affirming therapy“ (PHARMAC, 2023). This decision has significant implications for the health of all New Zealanders, but particularly women and girls.    

New Zealand has a unique drug regulatory environment. It also has a recent history of patient harm involving women’s health. One such scandal, the cervical cancer scandal, known as the “Unfortunate Experiment,” (Coney & Bunkle, 1987) involved withholding treatment for women with abnormal smears, and as a result some women died of cancer. This scandal, and the subsequent Cartwright Inquiry, (National Screening Unit, 1988) resulted in the formation of a Health and Disability Commission (Health and Disability Commissioner, n.d.) that handles complaints about breaches of its Code of Patient Rights (Health and Disability Commission, 1996). Most complaints are not investigated further, but when they are, the most serious sanction takes the form of a compelled apology to the harmed patient or their surviving family. And New Zealand has a unique medicolegal environment where patients cannot sue their doctors if they are harmed in all but the most extreme circumstances.

This makes drug regulation singularly important in New Zealand. Decisions about what drugs may be sold, and their availability through funding schemes are both important because patients can be harmed when certain drugs they need are inaccessible to them, but also when they are exposed to inappropriate drug treatment or harmed by medical devices.

In New Zealand, there is a crown entity called PHARMAC which funds large numbers of medicines. Other medicines are available, but the full cost must be paid by the patient, or, uncommonly in New Zealand, by their private medical insurance. New Zealand is a small country, and there is not a big market for drugs that treat rare diseases or a large insurance base to absorb the costs of the latest drugs marketed by pharmaceutical companies to treat more common problems. So New Zealanders came up with an innovative solution to tackle this problem: PHARMAC. 

PHARMAC is a sort of pre-paid drug store belonging to the NZ public. Medicines that are part of the PHARMAC scheme are available at little or no cost to patients when they are prescribed by doctors. The drug budget of PHARMAC is not unlimited, and the funding comes from the taxpayer, who should expect wise stewardship of their money. Because of resource constraints when one drug is funded, it necessarily means other drugs cannot be funded. The contracts to supply drugs are lucrative for suppliers who tender to enter single supplier arrangements with PHARMAC. These arrangements provide the public with a bulk buyer discounted price, and savings are passed on to the taxpayer who is, in turn, able to fund more drugs. 

But PHARMAC is not just a procurement organisation. It also makes judgments about drugs: for example, are they value for money? The value of a drug is about whether the impact of the drug treatment to the individual and to the public can be justified. Unfortunately, there is much evidence that drug companies magnify the benefits and minimise harms of their products to upsell them. And there is also evidence that patient advocacy groups and the key opinion leaders of medical organisations are influenced by drug companies as well. The duty of the drug company is to shareholders not to patients. But PHARMAC is meant to be an independent decision-maker. It is supposed to make decisions based on evidence of a “clear health benefit for New Zealanders” taking into consideration the advice of clinical experts from across New Zealand’s healthcare sector (PHARMAC, n.d.). Thus, both PHARMAC and the tendering approach of, “principal supply status” are approaches unique to New Zealand (PHARMAC, 2020). This competitive approach offers pharmaceutical companies the chance to win a protected contract for outyears in return for lower per unit pricing, and for hospitals and retail pharmacies to buy drugs at guaranteed low prices. The contractual details are highly confidential, as this maximises the competitiveness of tendering.

What appears to have driven the need for a single supplier contract is surely the massively increasing population of women and female adolescents using testosterone as a cross-sex imitation hormone. Prior to the availability of a gel-based product, the only funded testosterone available to patients was an injectable form, that was not funded for use by women, and normally used by men with congenital syndromes or serious acquired conditions affecting their own testicular production. The question that arises then is whether the use of testosterone gel for women who think they are men is the “clear health benefit for New Zealanders” (PHARMAC, n.d.) that PHARMAC’s purchasing criteria require. For this population, the use of testosterone is:

• Often driven by homophobia and other external factors such as trauma and autism syndrome conditions (ASD) (Badenoch, 2024; Cooke, 2023; Laval, 2021).
• Associated with many negative health impacts including and beyond its virilising effects period pain and pain on orgasm (VanDevater, 2023) and increased risk of cardiovascular disease (Alzahrani et al., 2019). 
• Used off-label with its use contra-indicated in women according to the Ministry of Health’s Medsafe datasheets (Medsafe, 2023).
• Being prescribed to a population where transition appears to take place in friendship groups and after following influencers on social media (Littman, 2018; Sapir et al., 2023).
• Associated with concerns about the transfer of skin-applied testosterone to people living with and intimate with the patients, a highlighted risk in the Medsafe datasheets.
• A category X teratogen, which normally should raise concerns about use in a population of women in their childbearing years. (United States Food and Drug Administration, 2015).

There are several other features of gender medicine practice in New Zealand that make for a sizable market for testosterone and a risky prescribing environment for patients. New Zealand has an extreme approach to the affirmation of people self-reporting as transgender (Rivers, 2023); policies that support the supply of cross-sex hormones with no qualifying medical criteria at all (Ker et al., 2021; Oliphant et al., 2018), and a novel and misleadingly named approach to informed consent which is defined as reaffirming “the self-determination of the transgender person and their knowledge of their needs, identities, and self” (Oliphant et al., 2018). This replaces the usual process of medical diagnosis (Lane, 2023).

There is also pressure to move gender medicine out of specialist hospital-based clinics which are part of the funded specialist care setting which have substantial waiting lists, into general practice (Carroll et al., 2022; Radio New Zealand, 2022). This is with minimal or no support from the integrated medical teams that the NZ 2018 Guidelines for gender-affirming healthcare argued were required only a few years ago (Oliphant et al., 2018). A massive increase in transgender presentations was first observed in New Zealand as long ago as 2018 (Delahunt et al., 2018), but there is also evidence that the number of young people on puberty blockers in New Zealand has increased ten-fold in a decade and that New Zealand’s rate of prescribing them is tenfold that of the disgraced English Gender Identity Development Service (GIDS) which is part of the Tavistock Clinic, within the National Health Service (Tegg, 2023). All these factors in addition to the statutory bar to lawsuits in the case of patient harm will provide an even larger recruitment pool for testosterone use in the future.

Whether this funding decision is a wise course of action will become apparent over time. New Zealand’s Ministry of Health is approaching the issue in a way that is very different to other countries such as England (Cass, 2022; National Institute for Health and Care Excellence, 2020); Sweden (Ludvigsson et al., 2023) and Finland (Pasternack et al., 2019) who each completed systematic reviews of the evidence relating to gender-affirming care for children, and Florida (Brignardello-Petersen & Wiercioch, 2022) where an overview of systematic reviews was commissioned. These independent evidence-based reviews have led to approaches that favour psychotherapeutic interventions over “gender-affirming care”. They also demonstrate that the basis for the approach being taken in New Zealand is heavily contested, and the evidence base in favour of “gender-affirming care” is lamentably poor. Other research has shown that homophobia, trauma, autism syndrome disorders (ASD) and social contagion are signal causes of the high rates of gender transition (Cass, 2022; Kozlowska et al., 2021; Littman, 2018; Sapir et al., 2023). It is surely unusual to be using a government agency to provide medications that alter bodies in a population that has a high level of co-morbid mental health conditions, and which, contrary to usual medical practice, is based on their own self-reported perception.

The emerging story overseas is one that demands attention and raises question marks over New Zealand’s approach to addressing healthcare system harm, its highly medicalised approach to gender, and the way this new contract was approved. The increasing number of court cases (Ayala, 2023; Griffiths, 2023), and traumatised detransitioners overseas (Respaut et al., 2022) point to the serious ethical issues in play. With its no-fault system, the New Zealand courts will not be available to harmed women and the most they can hope for is an apology from the Health and Disability Commission if they come to understand that their rights to true informed consent have been breached. It appears that recent steps to diminish the usual checks and balances that would support safe prescribing have created a dangerous situation for New Zealand’s women and girls as well as PHARMAC’s own reputation.

What we need to ask now is where are PHARMAC’s ethics when their purchasing decisions have opened a Pandora’s Box of poor practice?  

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Photo by Kyle on Unsplash

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References

Alzahrani, T., Nguyen, T., Ryan, A., Dwairy, A., McCaffrey, J., Yunus, R., Forgione, J., Krepp, J., Nagy, C., Mazhari, R., & Reiner, J. (2019). Cardiovascular Disease Risk Factors and Myocardial Infarction in the Transgender Population. Circulation: Cardiovascular Quality and Outcomes, 12(4), e005597. https://doi.org/10.1161/CIRCOUTCOMES.119.005597

Ayala, I. M. (2023). Isabelle M. Ayala vs American Academy of Pediatrics, Jason Rafferty, Michelle Forcier, Meghan Gibson, Gillian Morris, Brittany Allen, Ilana Sherer, Jill Wagner, John Does 1-15, & Lifespan Physician Group Inc. Case Number: PC-2023-05428. Filed in Providence/Bristol County Superior Court. Submitted: 10/23/2023.  https://www.iwf.org/wp-content/uploads/2023/10/ISABELLE-AYALA-LAWSUIT.pdf

Badenoch, K. (2024). Letter to the UK Government’s Women and Equalities Select Committee: Data on gender identity services. https://committees.parliament.uk/publications/43255/documents/215243/default

Brignardello-Petersen, R., & Wiercioch, W. (2022). Let Kids be Kids: Effects of gender affirming therapies in people with gender dysphoria: Evaluation of the best available evidence. Florida Agency for Health Care Administration. https://www.ahca.myflorida.com/letkidsbekids/docs/AHCA_GAPMS_June_2022_Attachment_C.pdf

Carroll, R., Nicholls, R., Carroll, R., Bullock, J., Reid, D., Sheilds, J., Johnson, R., Oliphant, J., McElrea, E., Whitfield, P., & Veale, J. (2022). Aotearoa New Zealand guidelines for commencing gender affirming hormone therapy (GAHT) for adults in primary care. Royal New Zealand College of General Practitioners. https://rnzcgp.informz.net/RNZCGP/data/images/Final%20draft%20of%20primary%20care%20guidelines%20for%20RNZCGP%20comment.pdf

Cass, H. (2022). Interim report – Cass Review. The Cass Review. https://cass.independent-review.uk/publications/interim-report/

Coney, S., & Bunkle, P. (1987). An Unfortunate Experiment. Metro, June, 48–65. https://www.womenshealthcouncil.org.nz/site/aklwhc/An_Unfortunate_Experiment-Metro_magazine1987-compressed.pdf

Cooke, R. (2023). Time to Think by Hannah Barnes, review – what went wrong at Gids? The Guardian, February 19. https://www.theguardian.com/books/2023/feb/19/time-to-think-by-hannah-barnes-review-what-went-wrong-at-gids

Delahunt, J. W., Denison, H. J., Sim, D. A., Bullock, J. J., & Krebs, J. D. (2018). Increasing rates of people identifying as transgender presenting to Endocrine Services in the Wellington region. New Zealand Medical Journal, 131(1468), 10. https://www.nzma.org.nz/journal-articles/increasing-rates-of-people-identifying-as-transgender-presenting-to-endocrine-services-in-the-wellington-region

Griffiths, S. (2023). ‘NHS trans surgery damaged my body for ever—It’s not safe’. The Times. June. https://www.thetimes.co.uk/article/nhs-trans-surgery-damaged-my-body-for-ever-its-not-safe-jt2hhbrgk

Health and Disability Commission. (1996). Code of Health and Disability Services Consumers’ Rights Regulations 1996. Health and Disability Commission. https://www.legislation.govt.nz/regulation/public/1996/0078/latest/whole.html?search=qs_act%40bill%40regulation%40deemedreg_%22informed+consent%22_resel_25_h&p=1#DLM209085

Health and Disability Commissioner. (n.d.). https://www.hdc.org.nz/

Ker, A., Fraser, G., Fleming, T., Stephenson, C., da Silva Freitas, A., Carroll, R., Hamilton, T. K., & Lyons, A. C. (2021). ‘A little bubble of utopia’: Constructions of a primary care-based pilot clinic providing gender affirming hormone therapy. Health Sociology Review, 30(1), 25–40. https://doi.org/10.1080/14461242.2020.1855999

Kozlowska, K., Chudleigh, C., McClure, G., Maguire, A. M., & Ambler, G. R. (2021). Attachment Patterns in Children and Adolescents with Gender Dysphoria. Frontiers in Psychology, 11. https://doi.org/10.3389/fpsyg.2020.582688

Lane, B. (2023). Misguided. Gender Clinic News. November 16.https://www.genderclinicnews.com/p/misguided

Laval, M. (2021). Transition in hindsight: Aaron Kimberly’s story. Genspect, July 26. https://genspect.org/transition-in-hindsight-aaron-kimberlys-story/

Littman, L. (2018). Parent reports of adolescents and young adults perceived to show signs of a rapid onset of gender dysphoria. Plos One. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0202330

Ludvigsson, J.F., Adolfsson, J., Höistad, M., Rydelius, P-A., Kriström, B., & Landén, M. (2023). A systematic review of hormone treatment for children with gender dysphoria and recommendations for research. Acta Paediatr. 112(11), 2279–2292. https://pubmed.ncbi.nlm.nih.gov/37069492/

Medsafe. (2023). Medsafe data sheet Testogel Gel. https://www.medsafe.govt.nz/profs/Datasheet/t/testogelGel.pdf

National Institute for Health and Care Excellence (NICE). (2020). Evidence review: Gender-affirming hormones for children and adolescents with gender dysphoria. https://segm.org/sites/default/files/20210323_Evidence%2Breview_Gender-affirming%2Bhormones_For%2Bupload_Final_download.pdf

National Screening Unit. (1988). The Cartwright Inquiry, National Screening Unit. https://www.nsu.govt.nz/health-professionals/national-cervical-screening-programme/legislation/cervical-screening-inquiry-0

Oliphant, J., Veale, J. F., MacDonald, J., Carroll, R., Harte, M., Stephenson, C., & Bullock, J. J. (2018). Guidelines for gender affirming healthcare for gender diverse and transgender children, young people, and adults in Aotearoa. Transgender Health Research Lab, University of Waikato. https://researchcommons.waikato.ac.nz/bitstream/handle/10289/12160/Guidelines%20for%20Gender%20Affirming%20Health%20low%20res.pdf

Pasternack, I., Söderström, I., Saijonkar, M., & Mäkelä, M. (2019). Sukupuolidysforia vaikuttavuusraportti _Verkkoon.pdf [Medical approaches to treatment of dysphoria related to gender variations. A systematic review]. https://app.box.com/s/y9u791np8v9gsunwgpr2kqn8swd9vdtx

PHARMAC. (n.d.). How Pharmac works. PHARMAC. https://pharmac.govt.nz/about/what-we-do/how-pharmac-works

PHARMAC. (2020). Decision to change PHARMAC’s approach to competitive procurement. https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/decision-to-change-pharmacs-approach-to-competitive-procurement

PHARMAC. (2023). Pharmac proposing to fully fund testosterone gel for all who need it. PHARMAC, November 8. https://pharmac.govt.nz/news-and-resources/news/2023-11-08-pharmac-proposing-to-fully-fund-testosterone-gel-for-all-who-need-it

PHARMAC. (2024). Pharmac to fully fund testosterone gel for all who need it. https://pharmac.govt.nz/news-and-resources/news/2024-02-08-pharmac-to-fully-fund-testosterone-gel-for-all-who-need-it

Radio New Zealand. (2022,). Government boosts funding for rainbow and intersex health services. RNZ, June 5. https://www.rnz.co.nz/news/political/468550/government-boosts-funding-for-rainbow-and-intersex-health-services

Respaut, R., Terhune, C., & Conlin, M. (2022). Why detransitioners are crucial to the science of gender care. Reuters, December 22. https://www.reuters.com/investigates/special-report/usa-transyouth-outcomes/

Rivers, J. (2023). An assessment of the PATHA guideline. https://www.publicgood.org.nz/wp/wp-content/uploads/2024/01/table-claims-refuted.pdf.docx

Sapir, L., Littman, L., & Biggs, M. (2023). The U.S. Transgender Survey of 2015 Supports Rapid-Onset Gender Dysphoria: Revisiting the “Age of Realization and Disclosure of Gender Identity Among Transgender Adults”. Archives of Sexual Behavior. https://doi.org/10.1007/s10508-023-02754-9

Tegg, S. (2023). Puberty Blocker Use in NZ: Overmedicalization or Unmet Need? Genspect, Australia/New Zealand webinar November 10. https://www.youtube.com/watch?v=P7PpqBIBZwI&list=PLmsMIEB9bK5xn_fAF7lZ73bPAVRbBpJ-Y&index=4

United States Food and Drug Administration (FDA). (2015). Testosterone gel, for topical use. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203098s009lbl.pdf VanDevater, K. (2023). Pelvic pain common for people using gender-affirming testosterone therapy. Healio News Service. https://www.healio.com/news/womens-health-ob-gyn/20230131/pelvic-pain-common-for-people-using-genderaffirming-testosterone-therapy