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Parents of gender-confused kids demand investigation of gov't-funded study on puberty blockers

Building 45 Natcher, home of the NIH Visitor Center and Nobel Laureate Exhibit Hallin Bethesda, Md., May 24, 2012.
Building 45 Natcher, home of the NIH Visitor Center and Nobel Laureate Exhibit Hallin Bethesda, Md., May 24, 2012. | (Photo: Courtesy of the National Institutes of Health)

Parents whose children were harmed by the medicalization of gender, specifically puberty-blocking drugs, cross-sex hormones and surgical interventions, are asking the Surgeon General to increase public awareness of the dangers of these irreversible medical practices.

A nonpartisan group called the Kelsey Coalition delivered on Friday a strongly-worded petition asking U.S. Surgeon General Jerome Adams to raise awareness about the harms of hormonal treatments and gender reassignment surgeries being performed on gender-nonconforming youth. These treatments and procedures are being done without one long-term study backing their safety or efficacy, they say.

"Parents who consent to these treatments are often misled to believe that their child will be at greater risk of suicide if they do not. There is no evidence to support this claim. In Oregon, parental consent is irrelevant: the law allows 15-year-olds to receive state-subsidized hormonal treatments and surgeries without parental knowledge or permission," the petition says. The petition also highlights concerns about the hastiness with which these medical and surgical pathways are being opened up to young people.

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"An increasing number of 'informed consent' clinics provide cross-sex hormones to young people after only one or two visits. These clinics do not require mental or physical health assessments. Surgeries may be obtained within months."

The medical repercussions from the use of these treatments will not be seen for years, the petition adds, citing the results of a large cohort study from the American Heart Association on thousands of transgender-identifying adults that shows significant risks to their cardiovascular health. Trans-identifying females on the hormones were three times as likely to have heart attacks, the research letter from the study explains; trans-identifying males on the drugs were at five times greater risk of developing venous thromboembolism.

Among those supporting the petition is Lynn Millican, founder of the Lupron Victims Hub. Lupron is a drug used to treat sex offenders, prostate cancer patients, and children with precocious puberty, but has never been through an FDA approval process for gender dysphoria and is prescribed off-label. Dr. Susan Bradley, a Canadian psychiatrist known for her work on gender identity disorder in children, is also backing the effort.

Michael Laidlaw, an endocrinologist from Rocklin, California, who has been one of the most vocal doctors speaking out about the dangers of these practices, told The Christian Post in a Monday interview that he feels strongly that the Surgeon General must be alerted to the long-term consequences of these drugs on young bodies, arguing that the treatments have no benefit to kids with identity confusion as it relates to their biological sex.

"Understand that mega-doses of testosterone are being given to teenage girls, some 10 to 40 times higher than what is normal for their body. Is it any wonder that follow-up studies in adults have shown an increased risk of myocardial infarction and death at these doses?" Laidlaw said.

"Puberty is not a disease," he emphasized, adding that some doctors are causing the disease of hypogonadotropic hypogonadism when they administer medications like Lupron for this purpose.

Side effects of puberty-suppressing drugs like Lupron include abnormal bone and brain development along with sex organ stunting, dysfunction, and potential sterility, he added.

"As the Surgeon General is the nation's doctor and has shown great leadership in the opioid crisis, we expect a thorough examination and action to stop these harmful, life-altering, unproven medical treatments," he said.

The Kelsey Coalition is also petitioning the federal government for an investigation into a $5.7 million National Institutes of Health research grant that was awarded to four pediatric gender clinics in 2015 for a five-year study, where children are being given these treatments with no control group.

As part of their efforts, Laidlaw wrote a letter to Dr. Jerry Menikoff, the director of the Office of Human Research Protections at the Department of Health and Human Services, expressing his concerns with the grant, providing copies of that letter to HHS Secretary Alex Azar and NIH director Francis Collins. He received a response on May 23 from Dr. Diana Bianchi, director of the National Institute of Child Health and Development.

Bianchi's letter of reply — which was obtained by CP — says the study being conducted was "observational" and accepts as an uncontestable truth that the youth participating in it are in fact transgender.

The main purpose of the research, the NICHD director said, is "to gather evidence" on the hormonal interventions used in pursuit of "longitudinal outcomes of medical treatment for transgender youth." This data that the researchers collect is then to be used to inform the medical community about "potential yet unknown benefits or risks that may lead to changes in current guidelines for such individuals."

Because few studies exist on this particular patient population, the data they are assembling is "critical to assure improved outcomes," the letter states, citing as supporting evidence an article in Nature Reviews Endocrinology on puberty suppression in gender identity disorder. The grant application, she said, went through a "rigorous peer review process," received a "highly meritorious score" in the study section — indicating that the medical community would value the research — and that the advisory council for the agency also reviewed it.

Bianchi also noted that the NICHD staff "rigorously reviewed" the grant each year and that the final funding decision for the study was made by her predecessor, Dr. Alan Guttmacher.

What the letter obfuscates is that these treatments are experimental, and no blood test, brain imaging scan, or DNA markers have ever shown the presence of a "gender identity" or that a child is transgender, apart from his or her biological sex. The letter also notably omits — as Laidlaw and his colleagues ultimately uncovered through FOIA requests — that a 2017 progress report for one of the grantees revealed that cross-sex hormones were being given to children as young as 8 years old.

"We must keep in mind that there are Institutional Review Boards which are designed to provide ethical oversight of human research being conducted in the United States," Laidlaw told CP.

"This system was developed in response to atrocities in human experiments that occurred in Nazi Germany and also here in the U.S. during the Tuskegee syphilis study. It seems that in this NIH-funded study, the IRBs have failed the children."

Asked to respond to the NICHD director's claim that the research grant was merely "observational," the California-based endocrinologist said it amounts to "a distinction without a difference."

"It is the very same clinics providing the wrong sex hormones and blocking normal puberty who are also administering the surveys and conducting blood sampling. This would be akin to Nazi soldiers taking body temperatures of prisoners while dunking them in freezing waters for hours, and then SS doctors publishing the data on body temperature, but claiming they had no part in the experiment."

He elaborated further on the ethics of the study: "Another part of the issue is consent. Can a child consent to procedures that will lead to future sterilization, for example? Do they have the intellectual capacity and life experience to even know what that means? They do not. So the child cannot provide meaningful consent, nor can their parent."

Laidlaw often posts on his Twitter feed easy-to-understand explanations about how hormones work, particularly how they function in the human endocrine system. He was locked out of his account last week. Although his feed remains online, the social media giant deemed as "abusive behavior" a reply-tweet he wrote questioning the notion of underlying "transness" in a depressed, anxious, or autistic child, and he is presently barred from using the platform.

The tweet for which Dr. Michael Laidlaw was locked out of his Twitter account on July 21, 2019.
The tweet for which Dr. Michael Laidlaw was locked out of his Twitter account on July 21, 2019. | Photo: Courtesy of Michael Laidlaw

"Then again, maybe every child is trans?!? Are we all missing something? Let's pop more pills and shoot up more kids!" he mused sarcastically about the medical interventions on the tweet thread. Laidlaw appealed the violation and it was rejected within an hour. He appealed again on July 22 and has not heard anything back since.

In March, members of the Kelsey Coalition met Laidlaw in Washington, D.C., and met with Rep. Andy Harris, R-Md., who is a member of the House Republican Doctor's caucus on Capitol Hill. Laidlaw told CP that Harris was friendly, receptive, and was concerned about the government-funded study.

CP reached out to the press secretaries for both Rep. Harris and the Republican doctors caucus to ask if any action was being taken. This article will be updated when a response is received.

Bill Mahoney, who hails from the Rochester area of New York, is one such parent who says he joined the Kelsey Coalition because it was the only organization he found that understands that the current “affirmative model” for transgender diagnosis and dealing with the related issues are seriously flawed. Earlier this year he explained his painful journey in a video on the coalition's YouTube channel.

Mahoney's 21-year-old son is currently enduring a third battle with cancer, he explained in an email to CP on Tuesday. Both the hospital where his son is being treated, Strong Memorial, and his son's college, Rochester Institute of Technology, fully support the affirmative model and consider him a "non-supportive parent" for not agreeing with his son’s self-diagnosis that he is female, he explained.

"My son’s medical situation is complicated by having a P53 gene mutation that predisposes him to cancer and transgender hormones are likely to accelerate the cancer growing genes," Maloney said.

"The school and hospital psychologists refused to consider the other awful things that have happened to him in evaluating his mental state, including losing his leg to cancer at age 2, losing his mother to cancer — same P53 genetic defect as his — while in grade school, acute blood loss during surgery in 2018, now dealing with stage 4 colon cancer, which has a poor prognosis."

The Kelsey Coalition is a nonpartisan organization whose mission is to promote policies and laws that protect young people from medical and psychological harms, according to their website. They are named after FDA pharmacologist Dr. Frances Kelsey, who in 1961 refused to bow to corporate and political pressure to authorize thalidomide for market use and thus prevented thousands of serious birth defects.

The most recent figures from the Centers for Disease Control say that 2% of U.S. high school students now self-identify as transgender.

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