Incriminating exposé could bring down Kamala Harris and the Biden administration
This White House has done nothing but lie. But it’s crossed a line never seen before.
And now an incriminating exposé could bring down Kamala Harris and the Biden administration.
An FDA team leader recommended approving “puberty blockers” for teens identifying as transgender despite a recent study linking these drugs to an “increased risk in depression and su*cidality.”
Activists often argue that children with gender dysphoria — a persistent condition of identifying with the gender opposite their biological s*x — must receive experimental drugs to make their bodies resemble those of the opposite s*x to prevent su*cide. However, the FDA study suggests these drugs may actually elevate the risk of su*cide.
In a January 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 had conducted a “safety review of the GnRH agonist class in pediatric patients in 2016/2017.”
GnRH, or “Gonadotropin-releasing hormone,” agonists prevent the natural release of testosterone and estrogen that initiate puberty.
America First Legal, a conservative nonprofit, obtained the email through the discovery process of a lawsuit and shared it with The Daily Signal.
“Our review focused on su*cidal ideation/depression, seizures, and bone health,” Sullivan wrote in the email. Most minors in the study had central precocious puberty (where puberty starts too early), but “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,” Sullivan noted.
“We did find increased risk of depression and su*cidality, as well as increased seizure risk and we issued [safety-related labeling changes].” Despite these findings, Sullivan recommended approving GnRH agonists for minors.
Sullivan explained that the FDA’s Division of Urology, Obstetrics, and Gynecology had conducted a patient listening session with trans kids and adults, noting a definite need for these drugs to be approved for gender transition since they are typically not covered by insurance and are expensive out of pocket.
“It was my understanding” that the FDA division “would take these applications if and when they do come in,” Sullivan added, even though no company had yet provided GnRH agonists for the transgender population.
Ian Prior, senior adviser at America First Legal, told The Daily Signal, “It is shocking and unacceptable that the FDA would admit that puberty blockers cause su*cidal ideation and depression, yet in the same breath recommend their approval for transgender ‘medical’ procedures for children.”
He added, “The advocates of these brutal practices on children claim that they are necessary to prevent su*cide and depression, but in reality, the treatments themselves cause the very thing they claim they are trying to prevent. 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 FDA for illegally concealing records related to the off-label use of “puberty blockers” and cross-s*x hormones on children.
They also filed a Freedom of Information Act request for all FDA records regarding the off-label use of “puberty blockers” and other drugs on children to provide “gender-affirming care,” a term critics argue is euphemistic for experimental interventions to make young men appear female and vice versa.
“Puberty blockers” and cross-s*x hormones can cause sterilization and other severe side effects, including depression, blood clots, high blood pressure, and weight gain. Internal documents from the World Professional Association for Transgender Health reveal that medical doctors supporting experimental treatments for children have acknowledged that side effects include liver cancer in teens and reduced s*xual 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 s*x offenders, to make young boys appear female. The FDA has approved GnRH agonists for central precocious puberty but not for gender dysphoria.
Sullivan’s email, obtained by America First Legal, emerged as FDA staff discussed responding to a media request from Reuters reporter Chad Terhune about “puberty blocking drugs” approved for central precocious puberty but used off-label for transgender children.
Stay tuned to the DC Daily Journal.
