FIRST ON THE DAILY SIGNAL—Sen. Ted Cruz condemned the U.S. Food and Drug Administration following news that an FDA team leader urged the approval of so-called puberty blockers for “transgender” minors, even while she acknowledged that these drugs are associated with an increased risk of suicide, depression, and seizures.
“These emails are beyond troubling,” Cruz, a Republican from Texas, told The Daily Signal in a written statement Monday. “The Biden-Harris administration has consistently put its radical gender ideology over the safety of children, and these emails strongly suggest that the FDA not only participated in those campaigns but actively knew that advancing them was endangering children.”
“Gender ideology” refers to the idea that a person’s internal sense of “gender” overrides his or her biological sex such that it is considered healthy to undergo experimental interventions.
Cruz referenced one email that emerged as part of an email chain.
In a Jan. 25, 2022, email, Shannon Sullivan, clinical team leader at the FDA’s Division of General Endocrinology, noted that the agency’s Division of Metabolism and Endocrinology Products performed a “safety review of the GnRH agonist class in pediatric patients in 2016/2017.” GnRH stands for “Gonadatropin-releasing hormone,” and GnRH agonists prevent the natural release of testosterone and estrogen that initiate puberty.
The conservative nonprofit America First Legal obtained the email in the discovery process of a lawsuit and made it available Thursday to The Daily Signal.
“Our review focused on suicidal ideation/depression, seizures, and bone health,” Sullivan wrote in the email. Although most of the minors in the study suffered from central precocious puberty (in which puberty starts too early), she said, “a handful were transgender kids using the drugs off-label.”
“We found no effect on bone (after factoring in catch-up growth), including no increase in fracture risk,” she noted. “We did find increased risk of depression and suicidality, as well as increased seizure risk and we issued [safety-related labeling changes].”
Yet Sullivan went on to recommend approving GnRH agonists for minors.
The FDA’s Division of Urology, Obstetrics, and Gynecology, she wrote, “has done a patient listening session with trans kids and separately with trans adults, which I participated in, and there is definitely a need for these drugs to be approved for gender transition, as they are typically not covered by insurance and are expensive out of pocket.”
Sullivan also said that “no company has come in” to provide “GnRH agonists in the transgender population” yet, but “it was my understanding” that the FDA division “would take these applications if and when they do come in.”
“It is shocking and unacceptable that the FDA would admit that puberty blockers cause suicidal ideation and depression, yet in the same breath recommend their approval for transgender ‘medical’ procedures for children,” Ian Prior, senior adviser at America First Legal, previously told The Daily Signal.
“The advocates of these brutal practices on children claim that they are necessary to prevent suicide and depression, but in reality, the treatments themselves cause the very thing they claim they are trying to prevent,” Pryor added. “This barbarism has no place in a civilized society and it’s time for the federal government to follow the lead of Europe in banning these experiments on children.”
America First Legal sued the Food and Drug Administration for illegally concealing records related to the off-label use of “puberty blockers” and cross-sex hormones on children. The organization also filed a Freedom of Information Act request for all FDA records regarding off-label use of “puberty blockers” and other drugs on children to provide “gender-affirming care,” a euphemistic term for experimental interventions to make young men appear female and vice versa.
“Puberty blockers” and cross-sex hormones may cause sterilization and other serious side effects including depression, blood clots, high blood pressure, and weight gain.
Internal documents from the World Professional Association for Transgender Health, which presents itself as the premier source on “gender-affirming care,” reveal that medical doctors who support experimental “treatments” for children have acknowledged that side effects include liver cancer in teens and reduced sexual function. They have also expressed concern about the lack of informed consent for procedures with lifelong impacts.
Some doctors prescribe Lupron, a drug also used to chemically castrate sex offenders, to make young boys appear female.
The Food and Drug Administration has approved GnRH agonists for central precocious puberty but not for gender dysphoria.
The FDA didn’t turn over requested documents in the timely manner required by law, so America First Legal sued. Sullivan’s email is among the documents the nonprofit obtained.
Sullivan originally sent the email as FDA staff discussed how to respond to a media request from Reuters reporter Chad Terhune. Terhune had asked about “puberty blocking drugs,” noting that such drugs have been “approved for central precocious puberty but [are] also used off-label for transgender children.”
The FDA did not respond to The Daily Signal’s request for comment by publication time.