The Food and Drug Administration (FDA) is under fire for backing the use of puberty blockers for transgender children, even when officials knew they presented life-threatening health risks.
Internal FDA emails obtained in a lawsuit show how officials knew the drugs, which delay the onset of puberty, raise the risks of users having seizures, depression, and committing suicide.
Even so, FDA team chief Shannon Sullivan wrote in a January 2022 email to colleagues that ‘there is definitely a need for these to drugs to be approved for gender transition.’
The revelations have drawn fierce criticism from Republicans, including Texas Senator Ted Cruz, who called the ‘beyond troubling’ and part of a broader effort to promote sex change care.
The FDA did not answer DailyMail.com’s request for comment.
FDA team leader Shannon Sullivan wrote that trans kids should get puberty blockers despite the health risks, documents show
The Food and Drug Administration (FDA) is charged with protecting public health by regulating and ensuring the safety and efficacy of products
Puberty blockers were originally developed to suppress the hormones of minors who started puberty too early.
They are nowadays prescribed to a fast-growing number of trans children.
Advocates of gender-affirming care, as it is known, say it’s life-saving for a suicide-prone group, and that puberty blockers help pre-teens ‘pause’ their puberty and buy time to weigh life-altering decisions.
Critics warn of surging numbers of young people who identify as trans, and say puberty blockers, cross-sex hormones and surgeries are often unnecessary and likely dangerous when counselling gets better results.
The FDA emails were obtained from the FDA by America First Legal, a conservative group, as part of a lawsuit, and were made 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 range of health problems.
This included on trans minors who used them ‘off-label’ — a relatively common practice of using medications for reasons beyond their intended purpose.
The blockers did not appear to impact the bone health of the young patients, as had been feared, wrote Sullivan.
But they did lead to ‘increased risk of depression and suicidality, as well as increased seizure risk,’ added the expert from the FDA’s endocrinology unit.
Even so, Sullivan said there is ‘definitely a need for these drugs to be approved for gender transition.’
This was because they are ‘typically not covered by insurance and are expensive out of pocket,’ she wrote.
The FDA has approved puberty blockers for children with early-onset puberty, but not for trans youth who seek to delay their physical maturation.
Lawmaker Cruz said the emails showcased how President Joe Biden’s administration is too supportive of ‘radical gender ideology.’
Most children who get treated with puberty blockers go on to cross-sex hormones, like this patient at Blue Mountain Clinic in Montana
Puberty blocker prescriptions continue to rise for trans youth in the United States
Chloe Cole, 19, who transitioned to male at 13 before later regretting her decision at 16, is among a growing number of young people who come to regret their trans treatments and seek to reverse them. She says she regrets taking puberty blockers at the age of 13 years
‘These emails strongly suggest that the FDA not only participated in those campaigns but actively knew that advancing them was endangering 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.’
‘The advocates of these brutal practices on children claim that they are necessary to prevent suicide and depression,’ Prior said.
‘In reality, the treatments themselves cause the very thing they claim they are trying to prevent.’
Republican lawmakers have outlawed puberty blockers and other types of trans care for minors in nearly two dozen states.
The row is expected to feature in the election fight between Kamala Harris, the Democratic Vice President who backs trans causes, and former Republican president Donald Trump, who vows to ban gender-affirming care for kids.
Norway, Finland, Sweden, Holland, and the UK are among a growing list of European countries that have restricted or wholesale stopped trans interventions on children.
In a landmark British report in April, top pediatrician Dr Hilary Cass made more than 30 recommendations to overhaul public health services in a bid to improve care offered to trans youth.
Her report took almost four years to produce and found children ‘caught in the middle’ of a toxic row over treatment have been set on a path to irreversible change.
She said evidence for using of puberty blockers and cross-sex hormones relied heavily on ‘shaky foundations’ and associated guidelines were not supported by science.
AFL lawyer Prior said the US should mirror its trans-Atlantic allies and outlaw medical ‘barbarism.’
‘It’s time for the federal government to follow the lead of Europe in banning these experiments on children,’ he said.
The legal action group, which is headed by former Trump administration officials, on Monday made a public records request to see all internal FDA correspondence about the drugs.
