The Food and Drug Administration (FDA) is under fire for endorsing the use of puberty blockers for transgender children even when officials knew they posed potentially deadly health risks.
Internal FDA emails obtained in a lawsuit It shows how officials knew the drugs, which delay the onset of puberty, increased users’ risks of seizures, depression and suicide.
Still, FDA team leader Shannon Sullivan wrote in an email to colleagues in January 2022 that “there is definitely a need for these drugs to be approved for gender transition.”
The revelations have drawn sharp criticism from Republicans, including Texas Sen. Ted Cruz, who called them “beyond troubling” and part of a broader effort to promote sex-change care.
The FDA did not respond to DailyMail.com’s request for comment.
FDA team leader Shannon Sullivan wrote that trans kids should be given puberty blockers despite health risks, documents show
The Food and Drug Administration (FDA) is charged with protecting the public health by regulating and ensuring the safety and effectiveness of products.
Puberty blockers were originally developed to suppress the hormones of minors who began puberty too early.
They are now being prescribed to an increasing number of trans children.
Proponents of gender-affirming care, as it is known, say it saves lives for a group prone to suicide, and that puberty blockers help preteens “pause” their puberty and buy time to consider life-altering decisions.
Critics warn of the growing number of young people identifying as trans, saying puberty blockers, cross-sex hormones and surgeries are often unnecessary and possibly dangerous when counselling yields better results.
The FDA emails were obtained by America First Legal, a conservative group, as part of a lawsuit and became available online late last month.
They show emails between Sullivan and other FDA officials about the safety of puberty blockers in response to a media request.
In the emails, Sullivan said the drugs were reviewed among young patients in 2016-17 to determine any links to a variety of health problems.
This included trans minors using them “off-label,” a relatively common practice of using medications for reasons beyond their intended purpose.
The blockers did not appear to affect the bone health of the young patients, as had been feared, Sullivan wrote.
But they did cause “an increased risk of depression and suicide, as well as an increased risk of seizures,” added the expert from the FDA’s endocrinology unit.
Still, Sullivan said, “There is definitely a need for these medications to be approved for gender transition.”
That’s because “they are typically not covered by insurance and are expensive to pay for,” he wrote.
The FDA has approved puberty blockers for children with early-onset puberty, but not for trans youth seeking to delay their physical maturation.
Rep. Cruz said the emails show how President Joe Biden’s administration is overly supportive of “radical gender ideology.”
Most children treated with puberty blockers go on to receive cross-sex hormones, like this patient at the Blue Mountain Clinic in Montana.
Puberty blocker prescriptions continue to rise for trans youth in the United States
Chloe Cole, 19, who became a man at 13 before regretting her decision at 16, is among a growing number of young people who regret their trans treatments and are seeking to reverse them. She says she regrets taking puberty blockers at the age of 13.
“These emails strongly suggest that the FDA not only participated in these campaigns but also actively knew that promoting them endangered children,” Cruz told The Daily Signal.
Lawyer Ian Prior called the emails “shocking and unacceptable.”
Ian Prior, the AFL lawyer leading the case, called the emails “shocking and unacceptable”.
“Defenders of these brutal practices against children claim they are necessary to prevent suicide and depression,” Prior said.
“In fact, the treatments themselves cause exactly what they claim to prevent.”
Republican lawmakers have banned puberty blockers and other types of trans care for minors in nearly two dozen states.
The dispute is expected to feature in the election fight between Kamala Harris, the Democratic vice president who supports transgender causes, and former Republican President Donald Trump, who is promising to ban gender-affirming care for children.
Norway, Finland, Sweden, the Netherlands and the UK are part of a growing list of European countries that have restricted or completely suspended transgender interventions in children.
In a landmark British report published in April, leading paediatrician Dr Hilary Cass made more than 30 recommendations for overhauling public health services in an attempt to improve care for trans young people.
Its report took nearly four years to produce and concluded that children “caught in the middle” of a toxic dispute over treatment have been set on a path to irreversible change.
She said the evidence on the use of puberty blockers and cross-sex hormones was largely based on “shaky foundations” and that associated guidelines were not supported by science.
AFL lawyer Prior said the United States should follow its transatlantic allies and ban medical “barbarism.”
“It is time for the federal government to follow the example of Europe and ban these experiments on children,” he said.
The legal action group, led by former Trump administration officials, on Monday filed a public records request to see all internal FDA correspondence about the drugs.