A team leader at the U.S. Food and Drug Administration (FDA) has recommended approval of puberty-suppressing drugs for minors who identify as “transgender,” despite concerns that studies have linked these drugs to increased depression and suicidal tendencies. The revelation strongly suggests that government-endorsed treatments ostensibly aimed at alleviating gender dysphoria may actually exacerbate mental health risks.
Internal documents released Thursday by the conservative nonprofit group America First Legal (AFL) reveal that Shannon Sullivan, clinical team leader in the FDA's general endocrinology division, briefed the division's director, Theresa Kehoe, in February 2022 about a safety study conducted by her team that found a correlation between the use of gonadotropin-releasing hormone (GnRH) agonists (commonly known as puberty blockers) and an increased risk of depression and suicidal thoughts among minors.
As the email reveals, the study, which focused on suicidal thoughts, depression, seizures, and bone health, primarily looked at minors with central precocious puberty (CPP, a condition in which puberty begins abnormally early). However, some of the study participants were “transgender” kids who were using the drug off-label. Sullivan said that while no significant issues with bone health were detected, the study did reveal an increased risk of depression, suicidal tendencies, and seizures. This latter finding led to a label change regarding the drug's safety.
Sullivan also acknowledged patient complaints including fibromyalgia (a chronic condition that causes widespread pain and tenderness throughout the body), infertility and weight gain.
Despite these concerns, Sullivan said “these drugs are definitely needed” for gender-confused youth and recommended moving forward with approval of the drugs. The FDA has not yet received a formal application for approval of GnRH agonists specifically for “transgender” minors, but Sullivan suggested that if such an application were submitted, the FDA would consider it.
She also noted that puberty suppressants are often not covered by insurance, making them cost-prohibitive for many families.
Ian Pryor, senior counsel at America First Legal, slammed the FDA for its stance on the drug, arguing that the agency is supporting a treatment that could harm the very children it is meant to help.
He said,
It is shocking and unacceptable that the FDA acknowledges that puberty blockers cause suicidal thoughts and depression, while at the same time recommending approval of sex-change “medical” procedures on children. Proponents of these cruel procedures on children claim they are necessary to prevent suicide and depression, when in fact the procedures themselves cause the very things they claim to be trying to prevent. Such barbarism has no place in a civilized society, and it is time for the federal government to follow Europe's lead and ban these experiments on children.
The group obtained the documents through a lawsuit it filed against the FDA on Feb. 28, 2023, alleging that the agency is hiding records about the off-label use of puberty suppressors and sex-change hormones in children. John Zadrozny, AFL's deputy director of research, spoke to The New American about the lawsuit shortly after it was filed.
At the heart of the lawsuit are concerns about the irreversible, life-altering damage that puberty suppressants and other federally approved drugs can cause to children, and the FDA's failure to disclose important information to the public. Zadrozny noted that one of the most commonly used puberty suppressants, Lupron, is also used to chemically castrate sex offenders. Moreover, he noted, many of these drugs are powerful chemotherapy agents that destroy cells and can cause sterilization, among other serious side effects.
HHS Recommends Puberty Suppressants
The FDA's parent agency, the U.S. Department of Health and Human Services (HHS), supports the use of GnRH agonists as part of so-called gender-affirming care for “transgender” minors.
According to the official guidelines, “Gender Reassignment Care of Youth,” prepared by the Office of Population Affairs (OPA) within the Office of the Assistant Secretary of Health (OASH), puberty suppressants are used to “pause” puberty development. The document states that the effects of using puberty suppressants are “reversible,” but medical experts dispute this.
Along with administering puberty-blocking drugs, the OPA recommends the use of social affirmations for gender-confused minors, such as “adopting gender-affirming hairstyles, clothing, names, gender pronouns, restrooms and other facilities,” as well as the use of cross-sex hormones for children (testosterone for girls and estrogen for boys) and surgical removal of breasts and genitalia.
It's worth noting that this guidance is just one part of the Biden administration's broader pro-transgender policy, which includes a range of policies from “strengthening federal protections for transgender children” to improving the travel experience for transgender people.
HHS Secretary Xavier Becerra has strongly supported the off-label use of puberty suppressants. According to a May 5, 2022 report by The New American, Becerra testified before Congress that the FDA would “send out a warning” if there were serious concerns about the safety of puberty suppressants.
Other countries
Several European countries, including the UK, Sweden and Finland, have recently scaled back the use of puberty blockers in minors, citing concerns about safety and long-term effects. These countries introduced more restrictive guidelines due to a lack of solid evidence supporting the treatment's effectiveness, as well as concerns about potential irreversible harms, such as effects on bone density and fertility. Recently, the UK's National Health Service (NHS) stopped routinely approving these treatments for people under the age of 16, and Sweden and Finland have similarly restricted their use, recommending them only in exceptional cases and within the framework of rigorous clinical trials.
