The Food and Drug Administration (FDA) is under fire for supporting the use of puberty blockers for transgender children, even though authorities knew the drugs were life-threatening to their health.
Internal FDA Emails obtained in a lawsuit show how officials knew the drugs, which delay the onset of puberty, increased users’ risk of seizures, depression and suicide.
Still, FDA team chief Shannon Sullivan wrote in an email to colleagues in January 2022 that “there is an absolute need for approval of these two drugs for gender reassignment.”
The revelations drew fierce criticism from Republicans, including Senator Ted Cruz of Texas, who called the revelations “more than disturbing” and called them part of a broader effort to promote gender reassignment care.
The FDA did not respond to DailyMail.com’s request for comment.
FDA team leader Shannon Sullivan wrote that trans children should be given puberty blockers despite the 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 whose puberty began prematurely.
Today, they are being prescribed to a rapidly growing number of transgender children.
Advocates of gender-affirming care, as it’s called, say it’s lifesaving for a group prone to suicide. In addition, puberty blockers are said to help preteens “pause” their puberty, giving them time to make life-changing decisions.
Critics warn about the growing number of young people identifying as transgender. Puberty blockers, hormones for transsexuals and operations are often unnecessary and even dangerous, while therapy produces better results.
The FDA emails were obtained from the FDA as part of a lawsuit by America First Legal, a conservative group, and made available online late last month.
They show emails between Sullivan and other FDA officials discussing the safety of puberty blockers, in response to a media request.
Sullivan wrote in the emails that the drugs were evaluated in young patients in 2016-2017 to determine possible links to various health problems.
This also applied to transgender minors who used the drugs “off-label”: a relatively common practice in which drugs are used for purposes for which they are not intended.
Sullivan wrote that the blockers did not appear to affect the bone health of the young patients, as had been feared.
But they did lead to “an increased risk of depression and suicidality, as well as an increased risk of seizures,” the expert from the FDA’s endocrinology division said.
Still, Sullivan said there is “certainly a need for approval of these drugs for gender reassignment.”
That’s because they are “usually not covered by insurance and are expensive out of pocket,” she wrote.
The FDA has approved puberty blockers for children with early puberty, but not for transgender youth who want to delay their physical development.
According to Congressman Cruz, the emails show that President Joe Biden’s administration is too supportive of “radical gender ideology.”
Most children treated with puberty blockers switch to cross-sex hormones, like this patient at the Blue Mountain Clinic in Montana
Puberty blocker prescriptions for trans youth in the United States continue to rise
Chloe Cole, 19, who transitioned to male at 13 and later regretted her decision at 16, is one of a growing number of young people who regret their trans treatments and are trying to reverse them. She says she regrets taking puberty blockers at 13
“These emails strongly suggest that the FDA not only participated in these campaigns, but actively knew that conducting them posed a danger to children,” Cruz told The Daily Signal.
Lawyer Ian Prior called the emails “shocking and unacceptable”.
Ian Prior, the AFL’s lawyer leading the case, called the emails “shocking and unacceptable”.
“Proponents of these cruel practices on children claim they are necessary to prevent suicide and depression,” Prior said.
‘In reality, the treatments themselves cause the very things they claim to prevent.’
Republican lawmakers have banned puberty blockers and other forms of transgender care for minors in nearly two dozen states.
The feud is expected to play a role in the election battle between Kamala Harris, the Democratic vice president who has championed transgender causes, and former Republican President Donald Trump, who wants to ban gender-affirming care for children.
Norway, Finland, Sweden, the Netherlands and the United Kingdom are among the growing list of European countries that have limited or even completely stopped trans interventions for children.
In a groundbreaking British report in April, leading paediatrician Dr Hilary Cass made more than 30 recommendations to reform the public health system to improve care for trans youth.
Her report, which took nearly four years to write, found that children who were “in the midst” of toxic conflict over treatment were on the path to irreversible change.
She said the evidence for the use of puberty blockers and cross-sex hormones was largely based on “shaky foundations” and the associated guidelines were not supported by science.
AFL lawyer Prior said the US should follow the lead of its transatlantic allies and ban medical “barbarism”.
“It is time for the federal government to follow Europe’s lead and ban these experiments on children,” he said.
The legal action group, which is led by former Trump administration officials, filed a public records request Monday seeking all internal FDA correspondence about the drugs.