In August, Liv Wyatt went to her local CVS drugstore in western Massachusetts to pick up a prescription for estradiol valerate–an injectable estrogen she’s used since she began transitioning to a woman six years ago. But when she arrived, the people at the counter said her prescription was not available. And no, they didn’t know why.
She went home empty-handed, called a pharmacist friend, and found out the truth: there were no refills. Not for her, not for anyone, because of a nationwide shortage of injectable estrogen. As of a few days ago, the drug deficit appears to be recovering. But the US government regulates estrogen for trans women using weird, wonky rules, so while injectable estrogen might be available now, the supply is unstable.
For trans women, estrogen treatments are essential for developing and maintaining a feminine body that is more closely aligned with their internal sense of self. A sudden loss of the hormone can result in emotional and physical trauma. Injectable estrogen isn’t the only way to get the right dose–doctors can also prescribe pills and topical patches, and have been doing so increasingly in the past few months. But each alternative comes with drawbacks. The pills must be taken every day and can be toxic to the liver. Patches irritate skin. And many people report that they just prefer the injections because they work better.
For Wyatt, who is in her 60s, those alternatives aren’t an option. Both carry an elevated risk of blood clots for older patients and her endocrinologist won’t even prescribe them. She was eventually able to buy injectable estrogen from a compounding lab in Portland, Oregon, but she knows many people who haven’t been quite so lucky. For one thing, not every state allows patients to order drugs from an out of state compounding pharmacy. So for women in North Carolina, for example, that’s not an option.
And of course, drugs from compounding pharmacies aren’t covered by insurance, even if you’re on public assistance. Wyatt says she pays about $100 for a 2-3 month supply. For the many trans women who are unemployed or underemployed, that’s a luxury they can’t afford. And even trans people with insurance often have to fight tooth and nail to get the promised coverage. The chronic shortages have created an underground market for hormones, which is a very risky, but potentially attractive option for trans women without access to legit supplies.
Injectable estrogen is available in three doses–10, 20 and 40 mg/mL–and all of them went on backorder a few months ago. It became a full-blown crisis this summer as the two most popular drugs for estrogen treatment therapy began to disappear from pharmacy shelves in record numbers. In August, when the FDA declared an official shortage of the generic estradiol valerate, and its brand name counterpart, Delestrogen, thousands of women like Wyatt found themselves scrambling for alternatives. “I’ve been taking these shots for six years, and I’ve never had a problem before these last 3-4 months” said Wyatt. “I got real close to the edge. I emptied the bottle and took every last drop I had.”
The story of a shortage
Delestrogen–made by Par Pharmaceuticals–was, until very recently, the only brand name FDA approved injectable estrogen. A few months ago, a supplier they contracted with stopped making one of the active ingredients. Par didn’t specify why. But they did get a new supplier, which means they need another approval from the FDA. Once that happens, the company has batches of each of the three doses manufactured and ready to ship. A rep for Par said the company, its supplier, and the FDA had been going back and forth for months, but were working diligently “to gain formal approval ASAP.” The FDA was not available to comment on the status of the approval process.
Perrigo Pharmaceuticals, based in Dublin, Ireland, makes the generic version of the estradiol valerate injection. They’ve had a shortage of one of the drug’s inactive ingredients. The company would not specify, but in the case of an injectable like this, the ingredient is likely either a preservative or the oil used to suspend the active ingredient for delivery into a patient’s muscle tissue.
While the 40mg/mL dose is still listed on the FDA’s shortage notice, a spokeswoman for Perrigo said the company actually released that dose from backorder as of October 6th. Pharmacies can now place orders and Perrigo will fill them. Which is great news for women who’ve been left in the lurch, like Wyatt. The 40mg/mL dose is the one most frequently prescribed to trans women because it provides the desired results with the fewest needle stabs. But advocates for transgender health are worried that getting pharmaceutical companies to restock supplies is just a short-term solution.
Estrogen for All?
Kimberleigh Joy Smith is a senior director at Callen-Lorde Community Health Center in Manhattan’s Chelsea neighborhood. Up until late July, the LGBT clinic offered estrogen injection treatments. More than 900 patients were impacted when its weekly supply dried up.
Smith sees the shortage as reflective of a regulatory environment that doesn’t value the transgender community. The FDA has approved no medications or treatments for the express purpose of helping people transition their bodies to reflect their gender identities. So what? Without that approval, insurance companies are less likely to cover its prescription costs. And that trickles down. “It’s our belief that if we as a community can convince the FDA to indicate it for the purpose of gender affirmation, there would be a bigger incentive on part of the manufacturer to keep it stocked appropriately and made available to all who need it,” Smith said.
As it is now, the FDA has only approved injectable estrogen for women going through menopause (you’ve probably heard it referred to as hormone replacement therapy). Doctors prescribing it to trans women use what’s called “off-label” discretion to do so, and while that’s been common practice for more than 60 years with no significant negative health outcomes, technically, it’s not sanctioned by the FDA.
Smith is organizing a plan to deliver these criticisms to the agency at a 2-day public hearing scheduled for November 9-10, regarding unapproved uses of approved FDA drugs. People like Wyatt are hopeful the hearing will draw some much-needed attention to a problem that isn’t a priority for the healthcare and pharmaceutical industries.
But she’s also a realist. “We’re basically off-script here,” she said. “And while for a lot of us we can really say that it’s saved our lives, we’re a very small population. It’s not cancer, and it’s not your mother or your brother. It’s the crazy person down the street that looks a little different. As it is, we have to live the shadows a little bit, and that’s why it just isn’t on people’s radar.”
Approving estrogen treatments specifically for trans women is a step the FDA could take toward legitimizing their health concerns. But legitimizing the rights of trans communities to be who they are? That’s on all of us. And it’s a much tougher prescription to fill.