Mazzoni Center has joined with several other health-care providers and LGBT organizations around the United States in calling on manufacturers of injectable estrogen to address the serious shortage that has been affecting trans women for the past several months. This shortage is affecting the availability of Delestrogen and its generic counterpart, estradiol valerate, in 40 mg/mL dosages, which is the preferred regimen for many transgender women.
Spokespeople for the companies that produce these injectable forms of estrogen have said there is a manufacturing delay for Delestrogen as well as manufacturing issues for the generic counterpart. Both companies apparently have these products on back order, but cannot estimate release dates.
We are concerned about the impact that lack of access to this form of estrogen could have on the many trans women in our care, and on trans women throughout the United States. We believe this shortage could lead to a significant public-health crisis if nothing is done.
Our colleagues at Callen-Lorde Community Health Center in New York City, Fenway Health in Boston and Treatment Action Group sent a letter to executives at Par Pharmaceutical and Perrigo, Inc. The letter — which has been co-signed by GLMA: Health Professionals Advancing LGBT Equality, Mazzoni Center and other organizations — states: “The impact of this shortage is a public-health emergency for thousands of transgender women who rely on these hormones to live whole and healthy lives.”
The letter goes on to say: “Hormone therapy to affirm gender identity is a medically necessary intervention for many transgender individuals. It is often the first, and sometimes only, medical gender-affirmation intervention accessed by transgender individuals looking to develop characteristics consistent with their gender identity. Studies have shown that gender affirmation through hormone therapy can improve psychological adjustment and quality of life. One study found that once estrogen therapy began, transgender women experienced improvement in social functioning and reduced anxiety and depression.”
It is important that people understand how essential these treatments are for trans women, a population that already faces high levels of marginalization and numerous barriers to accessing competent medical care.
It may be helpful to take a step back and review the role that hormones play in our bodies, and why they are a core component of health care for many trans people. Hormones are chemical messengers produced by the glands. They are released into the bloodstream, where they direct the activities and development of other cells. Hormones affect the appearance and growth of body fat, breasts, hair, reproductive organs and skin. They also help to regulate blood sugar, cholesterol levels and metabolism.
Hormone-replacement therapy (also referred to as HRT) for people assigned male at birth who are transitioning to female works to increase estrogen levels while lowering testosterone levels into a range more typical of cisgender females. A person on HRT will experience internal as well as visible/external changes to their body, essentially making their bodies more closely match their identity.
Many trans women have been taking injectable estrogen for years, and rely on regular injections to maintain their mental and physical health and well-being. Faced with a sudden lack of access, our concern is that some women may turn to street or black-market injections, which are often diluted or mixed with potentially harmful ingredients.
Providers at Mazzoni Center Family & Community Medicine, where I am on staff, began to see the impact of this shortage approximately three months ago. Since that time, we have been working with individual patients to explore alternatives to the 40mg/mL dosage of estrogen, including oral prescriptions and working with compounding pharmacies.
However, we are concerned — as are many of our colleagues in the field — that this shortage may last beyond the fall (when it was originally predicted that injectable estrogen would once again be available). For this reason, we are joining with our colleagues across the country and calling on Par Pharmaceutical and Perrigo, Inc., to do everything possible to address their manufacturing issues and ensure that access to injectable estrogen is restored as soon as possible.
Furthermore, our coalition of health-care providers and other community advocates is urging the FDA to take action by approving estrogen for gender affirmation, affording transgender women the same range of choices as menopausal women are currently given.
In the meantime, Mazzoni Center has long partnered with compounding pharmacies around the country for access to injectable hormones. We have options for injectable estradiol for those who want to use the generic/compounded product and we will continue to work with these partners to provide affordable products.
If you are a trans woman who has been taking injectable hormones and you have any concerns, I would encourage you to speak directly to your health-care provider. They can discuss the best options for your individual situation, and your continued good health.
Dane Menkin is a certified nurse practitioner and clinical operations manager at Mazzoni Center Family & Community Medicine, where he has worked since 2008. Dane is also on the faculty at Georgetown University School of Nursing.
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