By Mason Krohn
For most of the FDA researchers at the Center for Biologics Evaluation and Research, May 3, 2017 was a somewhat uneventful day — except for those who kept their eyes peeled on the campus televisions. Alas, as a leaked email from the department reveals, the Trump administration instructed the department to lock every screen in the building on the Fox News channel. The lack of remotes and plethora of Laura Ingrahams yelling into the halls of the FDA may seem inconsequential, but, in truth, the gesture symbolizes the growing conservative tilt within health agencies under the Trump administration. As RPR contributor Injae Lee investigated, within his first year in office, Trump banned words including “evidence-based”, “fetus”, and “transgender” from CDC reports. Furthermore, in surveys conducted by the Union of Concerned Scientists, 32 percent of FDA staff and 48 percent of CDC workers reported that the consideration of political interests at the agencies hinder science-based decision making. The Trump administration has even gone so far as to terminate federal recognition of trans identities by commanding the Department of Health and Human Services to alter the definition of gender under Title IX. In all cases, it appears that the federal government is chipping away at the research and study of LGBTQ+ issues through politicized attacks. However, these curtailments of governmental science are minor when compared to the slow and silent persecution of transgender communities perpetuated by the FDA, the healthcare system, and the pharmaceutical market in the form of injectable estrogen shortages.
For trans women, high doses of injectable estrogen are necessary to achieve desired feminine characteristics such as curvy hips, breasts, thinning face and hair growth. Though medical intervention is not necessary to be considered trans, a great amount of trans people opt for hormone therapy as a life-saving tool to alleviate their gender dysphoria. Researchers note that, for many patients, sex reassignment therapy (including hormone therapy) contributes to significant reductions in anxiety, depression, interpersonal sensitivity, hostility, and overall psychoneurotic distress. Any reduction in these symptoms is vital for members of the trans community in America, which faces a suicide rate 26 times the national average as reported by the largest survey of trans Americans to date. As renowned actress of Orange is the New Black, Laverne Cox, eloquently remarked, “Healthcare for trans women is a necessity. It is not elective. It is not cosmetic. It is life saving.”
Regardless of the evident cruciality of trans medical access, the path to hormone therapy is strenuous.Trans women seeking estrogen injections must first seek out a provider to write out a prescription. It seems like a simple task, but for trans women, this procedure is laden with barriers. First of all, 31 percent of transgender Americans lack regular access to health care. Discrepancies in access stem from stigma and ignorance from healthcare professionals; in fact, 22 percent of transgender people report avoiding doctors for fear of discrimination, which is of particular concern for sexual minorities in rural areas. Under the Church Amendments passed by Congress in the 1970s, medical practitioners in the United States reserve the right to reject any patients if the service contradicts their religion. Hence, even if trans women can overcome the fear of stigma, many doctors can turn them away out of hostility or sometimes out of pure lack of experience with trans patients. After all, in a Stanford University School of Medicine report, only 40 out of 132 U.S. and Canadian medical schools included content on gender transition in their curricula. Ultimately, stigma, inexperience, and legal discrimination have driven transgender patients away from medical spaces.
After jumping through the many hoops of trans primary care, severe shortages of injectable estrogen compound the difficulties of hormone therapy. Presently, a duopoly controls the market for injectable estrogen, leaving trans women with Delestrogen (a product of Par Pharmaceuticals) or Estradiol Valerate (a generic manufactured by Perrigo). A shortage of both substances commenced in July of 2016 and endured until June 12, 2017, but the only reasoning listed by the FDA was “shortage of an inactive ingredient component” for Estradiol Valerate and “other” for Delestrogen”. When the 2016 shortages took effect, Perrigo refused requests for comment by the Chicago Tribune, the Guardian, and Vice, offering no explanation for their withdrawal from the market. Par Pharmaceuticals, on the other hand, disclosed that when their supplier of Delestrogen’s main active ingredient pulled out, they had to alter their supply chain. By August 9, 2016 (within a month of the shortage commencing), Par representatives stated that thousands of Delestrogen vials were ready for sale. Nevertheless, Par had to await FDA approval of its new supplier before distributing the new Delestrogen. Therefore, the FDA is culpable for injectable estrogen shortages for over 10 months. It is understandable for the FDA to review the manufacturer for safety concerns, however, given the nature of the shortage, the FDA’s disregard for timeliness is more of an affront to the trans community than a sign of caution. Moreover, the FDA’s long winded scrutiny is suspicious given that there are 17 estrogen medications with approval from the FDA for cisgender menopausal women. Due to partial FDA incompetence and the lack of distributors in this field, trans women were left to suffer the consequences.
The question then arises: how did trans women who had been injecting high doses of estrogen last almost a year without any available supply? For some, the shortage entailed turning to the black market. Vendors on Deep Web marketplaces like Hansa and Valhalla link trans women to illicit producers largely based in India and the Philippines. Participating in these markets is dangerous, because hormones found there might be diluted or laced with harmful ingredients including but not limited to chalk and boric acid. Unfortunately, the only alternatives to the black market are estrogen pills or patches. Pills are less effective than injectable estrogen vials, come in lower doses than necessary, and pose the risk of blood clots. Patches are prohibitively expensive and are just as ineffectual as pills. At the end of the day, the shortage left trans women vulnerable and cut back on the progress many of them achieved with hormonal therapy.
Even though the combined shortage of Delestrogen and Estradiol Valerate concluded last year, the supply of injectable estrogen is still broadly sporadic and inaccessible. The cheaper generic, Estradiol Valerate, has repeatedly gone out of stock; in fact, the FDA currently lists the drug as “in shortage”. Hence, trans women’s only option is the name brand version, which is often outside of their budgetary restraints. Even then, Delestrogen tends to only be available in urban areas with steady demand, including New York, Los Angeles, and San Francisco. For Par Pharmaceuticals, there is little incentive to keep a supply in rural pharmacies, given that the trans community is only 0.6% of the US population and many trans Americans move to urban areas. Since Par faces little competition in the field, it can single-handedly decide the fate of trans citizens seeking hormone therapy by deciding price and distribution of the product.
So long as market barriers remain steep, no trans woman can count on the ready availability of the next prescription of estrogen. Without this access, issues of gender dysphoria and outrageously high suicide rates that are already alarming will proliferate in the trans community. Put simply, a quintessential treatment has been withheld from a disadvantaged group. It ultimately prompts the question: would trans women still face this reality if, instead of Fox News clamors, it was their painful stories that reverberated through the halls of the FDA?