The Gay and Lesbian Medical Association ( GLMA ) is sending this message from our colleagues at Callen-Lorde, Fenway and Treatment Action Group. GLMA has joined this sign-on effort and encourages individual providers and other LGBT health organizations to do so as well. The deadline to sign-on is Sept 2, 2016.
In collaboration with our LGBT health provider and community partners, Callen-Lorde, Fenway, and Treatment Action Group seek to address the national shortage of injectable estrogen ( in the 40 mg/mL dosage ). We hope that you will review and sign on to the letter below.
The impact of the injectable estrogen shortage poses a serious public health issue for transgender women across the country who rely on hormones to live whole and healthy lives. The shortage is affecting the availability of Delestrogen and its generic counterpart estradiol valerate. Manufacturers spokespeople have said that the products are on back order, but cannot estimate release dates. The shortage began 18 months ago and has not since returned to market. We do not want our communities to turn to street or black market injections, which can contain harmful ingredients. The shortage is generating interesting and important discussion about pushing the FDA to approve estrogen for gender affirmation for trans women, ensuring fair pricing as well as the pros and cons to injectable versus pills and patches.
Recent articles:
- www.theguardian.com/society/2016/aug/09/injectable-estrogen-shortage-transgender-healthcare .
- www.out.com/out-exclusives/2016/8/04/exclusive-theres-injectable-estrogen-shortage-thats-leaving-trans-women/ .
The sign-on letter below urges manufacturers to restock this dosage of estrogen. We hope you'll join this effort. Please review the letter below and sign on using this link ( feel free to share with your networks as well ): www.surveymonkey.com/r/R9MFNBQ. The deadline to sign on is September 2, 2016 .
Text of the letter is below.
Paul Campanelli
President
Par Pharmaceutical at Endo International PLC
One Ram Ridge Rd
Chestnut Ridge, NY 10977
John Hendrickson
Chief Executive Officer
Perrigo, Inc.
515 Eastern Avenue
Allegan, MI 49010
September 2016
Dear President Campanelli and CEO Hendrickson:
We the undersigned — physicians, public health professionals, advocates and members of the lesbian, gay, bisexual ( LGB ), transgender and gender non-conforming ( TG/NC ) communities — write to share our deep concern about the national shortage of injectable estrogen. We urge that Par Sterile and Perrigo Pharmaceuticals restock and manufacture injectable estradiol in 40 mg/mL dosages. 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.
Hormone therapy to affirm gender identity is a medically necessary intervention for many transgender individuals.[1] 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.[2] Studies have shown that gender affirmation through hormone therapy can improve psychological adjustment and quality of life.[3],[4] One study found that once estrogen therapy began, transgender women experienced improvement in social functioning and reduced anxiety and depression.[5] The class of estrogen used for feminizing therapy is 17-beta estradiol and is commonly delivered to transgender women through a patch, oral or sublingual tablet, or injection.[6]
Further, in the last 10 years, many professional associations, including the American Medical Association, American Association of Family Physicians, the Endocrine Society, American Psychiatric Association, American Psychological Association, American College of Obstetricians and Gynecologists, and the American Public Health Association, have issued statements or guidelines supporting effective treatment protocols for Gender Dysphoria, and review articles have been published in major peer-reviewed journals such as the Journal of the American Medical Association, Nature, the Journal of Clinical Endocrinology, and Archives of Pediatric and Adolescent Medicine, among others.[7]
As you are aware, there is a current shortage of estradiol valerate Injection.[8] This shortage is affecting the availability of Delestrogen and its generic counterpart estradiol valerate. The shortage includes Delestrogen injection from Par Sterile Products and estradiol valerate injection from Perrigo, in both the 20 mg/mL and 40 mg/mL formulations. We understand from Par and Perrigo spokespersons that there is a manufacturing delay for Delestrogen as well as manufacturing issues for the generic counterpart. We also understand that both companies have these products on back order, but cannot estimate release dates. While Delestrogen injection is currently available from Par Sterile Products in the 10 mg/mL formulation, [9] injectable estrogen at the 40 mg/mL dosage is the highest dosage and very often prescribed to transgender women in our experience.[10] The shortage began 18 months ago and has not since returned to the market. In July 2016, a federally-qualified health center based in New York City received none of the 40 mg/mL and 20 mg/mL formulations in their weekly drug shipment and were told that the shortage would last until at least October.[11] This shortage impacts 900 transgender women at that clinic alone.
Due to the severity of the effects of this shortage on the wellbeing of transgender women, we urge you — the manufactures — to take immediate action by restocking the 40 mg/mL dosage of injectable estrogen in both brand and generic versions.
Manufacturers need to restore the 40 mg/mL dosage of injectable estrogen because it is the preferred regimen for many transgender women. Many patients started their transition with injectable estrogen years ago and rely on regular injections. Further, many transgender women on hormone therapy for gender affirmation experience injectables as more effective than patches or pills. Some providers are working to educate patients about the efficacy of patches and pills; but this does not negate the immediate need for injectable estrogen.
While the 40 mg/mL dosage has been unavailable, providers have made due by doubling up on the 20 mg/mL dosage. This is a temporary work-around as some patients report discomfort with the injections. Most providers will not prescribe the 10 mg/mL dosage. In order to maintain the estrogen levels that patients were able to achieve with the 40 mg/mL dosage, patients would need to inject four times as much liquid into their muscles every one to two weeks, which can be very painful for patients.
The lack of injectable estrogen is a public health crisis. Patients could likely turn to street injections to replace what they were receiving in clinics, which could put themselves at risk. Black market injectable estrogen is often diluted or laced with other potentially harmful ingredients. This shortage could contribute to further marginalization of the transgender community, putting women at risk of injecting adulterated estrogen.
The shortage of this preferred method of gender affirmation therapy has already created obstacles for clinicians to be able to provide comprehensive care to transgender patients. This injectable estrogen shortage is triggered by a lack of FDA-approval for all estrogen modalities. Therefore, the FDA should also take action by approving estrogen for gender affirmation, affording transgender women the same range of choices as menopausal women are currently given. Advocates are working to this end.
In the meantime, thousands of transgender women across the United States are unable to access injectable estrogen thereby putting their health and lives in danger. We urge Par Sterile and Perrigo Pharmaceuticals to restock the 40 mg/mL dosage of injectable estrogen immediately. If helpful, we can arrange a conference call to discuss this further.
Please feel free to contact Kimberleigh J. Smith, Senior Director for Community Health Planning and Policy at the Callen-Lorde Community Health Center in New York City with questions and/or to send a response to this request: ksmith@callen-lorde.org or 212-271-7184.
Sign on list in formation
