‘ANTI-SCIENCE’: Former health officials slam FDA’s hypocrisy on “Regeneration Blockers” in light of new evidence.

EARLIER—Officials at the U.S. Department of Health and Human Services and the Food and Drug Administration criticized what they described as the FDA’s hypocrisy in allowing off-label use of so-called blockers while loudly criticizing safe drugs to treat COVID-19.

“During the Trump administration, the media falsely accused us every day of ‘politicizing America’s public health agencies.’ Yet the media has gone silent [Vice President Kamala] Harris and [President Joe] Biden’s FDA’s anti-science, it’s political nonsense,” Brian Harrison, former head of HHS and now a member of the Texas House of Representatives, told the Daily Signal in a written statement.

“Now we’ve learned that the same FDA that prevented mothers from injecting safe formula for starving babies and kept safe COVID treatments from patients appears to have been pushing dangerous blockers for children, ” Harrison added.

Shocking new evidence

Harrison pointed to an email obtained by the conservative organization American First Legal and first published by The Daily Signal.

In a January 25, 2022, email, Shannon Sullivan, clinical team leader in the FDA’s Division of General Endocrinology, noted that the Department of Metabolism and Endocrinology Products conducted a “safety review of a group of GnRH agonists in patients with children in 2016/2017.”

GnRH stands for “Gonadatropin-releasing hormone”. GnRH agonists block the release of testosterone and estrogen that initiate puberty.

“Our research focused on suicidal ideation/depression, concussions and bone health,” Sullivan wrote in a 2022 email. in precocious puberty (in which puberty begins very early), he said, “several were transgender children who were using off-label drugs.”

He said: “We found no effect on bone (after increasing the size of the catch), including no increase in fracture risk. “We found a risk of more depression and suicide, as well as an increased risk of depression and we gave it [safety-related labeling changes].”

However, as The Daily Signal reported, Sullivan continued to recommend receiving GnRH agonists for children.

The FDA’s Division of Urology, Obstetrics, and Gynecology, he wrote, “has made time to listen to the patient and trans kids and separately to adults, which I participated in, and it is really necessary that these drugs approved for gender reassignment, as they are often not covered by insurance and cost more out of pocket.”

Sullivan added that “no company has come in” to offer “GnRH agonists to transgender people” yet. However, he added, “it was my understanding” that the FDA section “will consider these applications if they come in.”

Transgender activists claim that transgender children need experimental medical treatments such as GnRH agonists to prevent puberty or force their bodies to conform to human bodies. of the opposite sex. Advocates disguise the nature of these measures under the term “gender-affirming care” and insist that without these measures, children will kill themselves.

Roger Severino, former director of the Office of Human Rights at HHS and now vice president of domestic policy at The Heritage Foundation, emphasized the inconsistency between the rhetoric supporting “care of equality” and the findings observed by Sullivan of the FDA.

“HHS keeps saying antibiotics for 12-year-olds are ‘reversible,’ apparently ignoring the fact that suicide is as irreversible as it is,” Severino scoffed.

FDA’s Duplicity on COVID-19, ‘Puberty Blockers’

David Gortler, a Yale University-trained pharmacist who was previously a senior adviser to the FDA commissioner on drug policy and safety, raised awareness about GnRH agonists for children.

Gortler told The Daily Signal that the Food and Drug Administration is “being proactive” with how it uses its 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 the reporting system to declare hydroxychloroquine unsafe after receiving only a few hundred reports of adverse events, he said, but the agency rejects a very high number of such reports. for GnRH agonists.

“GnRH agonists make 70,000 negative reports,” Gortler said. “While these reports still need to be investigated, they are a surprising number of adverse events for what should be a top, otherwise rarely reported, class of drugs.”

However the FDA often rejects these reports as “unconfirmed”; “to have no cause”; “there is no concrete evidence”; and “not setting the rate of events.”

Gortler, who analyzed the data himself, showed a preliminary analysis to The Daily Signal. According to his analysis, AERS reported 70,000 adverse reactions to GnRH agonists, 2,510 of which involved children 14 years of age or younger.

Adverse effects include vision, bone problems, heart attack, stomach pain, migraine, mood swings, heart attack, pelvic pain, falls, abnormal skin odor, blindness and the rest. Among patients aged 4 to 13, a total of 21 had suicidal thoughts.

The AERS database includes 30 reports showing the death of a patient between the ages of zero and 14 where a “blocker of puberty” is the main suspected drug.

These cases include a 10-year-old child who died of anemia after taking Lupron, a synthetic hormone, in March 2014; a 5-year-old child who died of cancer was reported in May 2022; an 8-year-old child who died of liver failure after receiving leuprolide acetate, a synthetic drug, in March 2004; and a 14-year-old who “finally took his own life” in April 2017.

“Even though this drug is not properly safe, they seem to be ignoring it, it seems to be consistent with the messages of the White House,” Gortler said, referring to FDA officials.

He added: “At the same time, the FDA was involved in the unscheduled administration of ivermectin and hydroxychloroquine, both of which were relatively safer than GnRH agonists, based on and clinical studies, randomized controlled trials, AERS reports, as well as other epidemiological studies.”

Where Do ‘Puberty Blockers’ Come From?

A former FDA consultant also told The Daily Signal that doctors developed GnRH agonists to help treat some types of cancer that depend on estrogen or testosterone.

Removing estrogen and testosterone from cancer patients to prolong their lives makes sense, Gortler said, because it prevents the development of an aggressive, dangerous disease. But giving these drugs to children who are physically and genetically healthy is a completely different story, he said.

“This drug was tested, developed, and approved by the FDA for use in elderly, cancer patients,” Gortler said.

“The human body has about 100 billion cells,” Gortler noted. “High school biology taught us that in each of those nucleated cells, there are XX or XY chromosomes that indicate sex, respectively. No drug or medical procedure will ever be able to fight 100 trillion cells, and trying to do so would be a fool’s errand.”

He compared “puberty restrictions” to the outdated, dangerous Chinese practice of foot binding, where a girl’s feet were tightly bound to prevent them from growing naturally.

“Similarly, GnRH agonists prevent the normal process of healthy development from occurring,” Gortler said. “Just because something isn’t directly and clearly visible doesn’t mean it’s less dangerous medically, scientifically or ethically.”

The FDA did not respond to The Daily Signal’s request for comment.