FIRST DAILY SIGNAL — Former officials from the U.S. Department of Health and Human Services and the Food and Drug Administration have criticized the FDA for duplicity in allowing the off-label use of so-called puberty blockers while vocally criticizing the use of much safer drugs to treat COVID-19.
“During the Trump administration, the media falsely accused us daily of ‘politicizing America’s public health agencies,’ yet those same media are now silent. [Vice President Kamala] Harris and [President Joe] “Biden’s FDA is anti-science and complete political insanity,” Brian Harrison, a former chief of staff at the Department of Health and Human Services and now a Texas congressman, said in a written statement to the Daily Signal.
“The same FDA that banned mothers from importing safe baby formula for starving babies and kept safe COVID treatments from patients is now apparently promoting puberty blockers that are dangerous to children,” Harrison added.
Shocking new evidence
Harrison pointed to emails obtained by the conservative nonprofit America First Legal and first published by the Daily Signal.
In a Jan. 25, 2022 email, Shannon Sullivan, clinical team leader for the FDA’s Division of General Endocrinology, said the agency’s Division of Metabolism and Endocrinology Products ” GnRH agonist class “It occurred in pediatric patients in 2016/2017.”
GnRH stands for “gonadotropin-releasing hormone.” GnRH agonists block the natural release of testosterone and estrogen, which trigger puberty.
“Our investigations focused on suicidal ideation, depression, seizures, and bone health,” Sullivan said in an email in 2022. The majority of minors in the study had central precocious puberty (puberty starting too early), but “a small number were transgender children who were using medications off-label,” she said.
“We found no effect on bone (after taking into account catch-up growth) and no increased fracture risk,” she noted. The risk of depression and suicide increases, as does the risk of seizures. [safety-related labeling changes].”
But as reported by the Daily Signal, Sullivan also recommended approval of GnRH agonists for minors.
“The FDA’s Division of Urology, Obstetrics, and Gynecology has conducted patient listening sessions, including with transgender children and separately with transgender adults, which I have attended, and there is no doubt that these drugs should be approved for gender transition treatments, as they are generally not covered by insurance and have high out-of-pocket costs,” she wrote.
Sullivan also said that “no companies have yet come forward” to “offer GnRH agonists for transgender people.” But she added that her understanding is that the FDA division would “accept a request if one were to come forward.”
Transgender activists argue that minors who identify with the opposite gender to their biological sex need experimental medical alterations, such as GnRH agonists, to block puberty or to make their bodies resemble the opposite gender. Activists cloak the nature of these interventions in the term “gender-affirming care” and claim that without these interventions, children would commit suicide.
Roger Severino, a former HHS civil rights director who is now vice president of domestic policy at the Heritage Foundation, highlighted the contradiction between the rhetoric supporting “gender-affirming care” and the research findings cited by the FDA’s Sullivan.
“The Department of Health and Human Services claims that puberty suppressants in 12-year-olds are completely ‘reversible,’ yet seems oblivious to the fact that suicide is most often irreversible,” Severino quipped.
FDA’s Dualism on COVID-19 and “Puberty Blockers”
David Gortler, a Yale-trained pharmacologist and former senior adviser to the FDA Commissioner on policy and drug safety, warned about the use of GnRH agonists in minors.
Gortler told The Daily Signal that the Food and Drug Administration has been “dishonest” in its use of the Adverse Event Reporting System (AERS), a database of reactions to certain drugs that users report to the FDA.
The FDA relied heavily on data from its reporting system to declare hydroxychloroquine unsafe despite finding only a few hundred reports of adverse events, but when it comes to GnRH agonists, the agency has rejected a significant number of such reports, he said.
“GnRH agonists have had 70,000 reported side effects,” Gortler said. “These reports still need to be reviewed, but for a niche drug class with few clinical indications, this is a staggering number of side effects.”
However, the FDA often dismisses these reports as “unconfirmed,” “causation not established,” “inconclusive evidence,” or “incidence not established.”
Gortler has analyzed the data himself, and presented his preliminary analysis to The Daily Signal. His analysis found that AERS has reported 70,000 adverse reactions to GnRH agonists, including 2,510 involving children under the age of 14.
Side effects include hallucinations, bone damage, cardiac arrest, abdominal pain, migraines, mood swings, blood clots in the heart, pelvic pain, seizures, abnormal skin odor and blindness. A total of 21 patients aged between 4 and 13 considered suicide.
The AERS database contains 30 records documenting deaths in patients aged 0 to 14 years where puberty blockers were the primary suspected drug cause.
These cases include a 10-year-old boy who died of a hemorrhagic stroke after taking the synthetic hormone brand Lupron in March 2014, a 5-year-old boy who died of cancer reported in May 2022, an 8-year-old boy who died of liver failure after taking the synthetic drug leuprorelin acetate in March 2004, and a 14-year-old boy who “committed suicide” in April 2017.
“Despite the fact that this drug is objectively unsafe, FDA officials appear to be selectively turning a blind eye to it in line with the White House messaging,” Gortler said, referring to FDA officials.
“At the same time, the FDA selectively delved into the off-label administration of ivermectin and hydroxychloroquine, which are relatively safer than GnRH agonists based on clinical studies, randomized controlled trials, AERS reports, and other epidemiological findings,” he added.
Where did “puberty blockers” come from?
The former FDA adviser also told The Daily Signal that doctors developed GnRH agonists to help treat certain cancers that depend on estrogen and testosterone.
Removing estrogen and testosterone to extend the lifespan of cancer patients makes sense because it prevents the progression of aggressive, malignant diseases, Gortler said, but administering these drugs to physiologically and genetically healthy children is an entirely different story, he said.
“This drug was tested, designed and approved by the FDA for older adults with cancer,” Gortler said.
“There are about 100 trillion cells in the human body,” Gortler points out. “In high school biology, we were taught that each nuclear cell has either XX or XY chromosomes, representing female or male. There is no drug or medical procedure that can combat 100 trillion or so cells, and it would be foolhardy to try to do so.”
He likened “puberty blockers” to the ancient and dangerous Chinese practice of tightly binding girls’ feet to prevent them from growing naturally.
“Similarly, GnRH agonists disrupt normal, healthy developmental processes,” Gortler says. “Just because they are direct and clearly invisible does not make them any less dangerous clinically, scientifically, or ethically.”
The FDA did not respond to The Daily Signal’s request for comment.
