(LifeSiteNews) — The U.S. Food & Drug Administration (FDA) has expressed interest in a proposed clinical trial pertaining to “transgender” hormone use, potentially indicating future formal approval of yet another method of the controversial chemical procedures.
Politico reports that the nonprofit Research Institute for Gender Therapeutics (RIGT) says it received promising feedback from the FDA on its proposal for a Phase III clinical trial on the use of the estrogen variant estradiol for certain seekers of so-called “gender-affirming care,” including adults and “some adolescents of reproductive age.” RIGT’s trial would begin in 2025.
The FDA’s receptiveness to the trial is seen as significant because it could be a precursor to official FDA approval of the hormone for “gender transition” purposes. As a practical matter, estradiol is already being prescribed for “transitions,” but that use is technically off-label.
FDA approval would give greater legal and political weight to attempts to cover transgender hormones in insurance plans and to legal efforts to strike down laws prohibiting chemical “transitioning” for minors, according to Yale Medical School’s Dr. Meredithe McNamara and Dr. Madeline Deutsch, medical director of the University of California-San Francisco’s “Gender Affirming Health Program.”
Gender “transitioning” is promoted as a necessity to resolve the mental and emotional trauma associated with gender dysphoria, but a body of evidence indicates that its real net impact is the opposite.
Studies find that more than 80% of children experiencing gender dysphoria outgrow it on their own by late adolescence, and that even full “reassignment” surgery often fails to resolve gender-confused individuals’ heightened tendency to engage in self-harm and suicide — and may even exacerbate it, including by reinforcing their confusion and neglecting the actual root causes of their mental strife.
This summer, the Biden administration’s own U.S. Department of Health & Human Services (HHS) Substance Abuse & Mental Health Services Administration (SAMHSA) released a since-deleted report that acknowledged “lesbian, gay, and bisexual adults are more likely than straight adults to use substances, experience mental health conditions including major depressive episodes, and experience serious thoughts of suicide.”
Many oft-ignored “detransitioners,” individuals who attempted to live under a different “gender identity” before embracing their sex, attest to the physical and mental harm of reinforcing gender confusion, as well as to the bias and negligence of the medical establishment on the subject, many of whom take an activist approach to their profession and begin cases with a predetermined conclusion that “transitioning” is the best solution.
Some such physicians have also been caught on video admitting to more old-fashioned motives for such procedures, as with an exposé last year about Vanderbilt University Medical Center’s Clinic for Transgender Health, where Dr. Shayne Sebold Taylor said outright that “these surgeries make a lot of money.”