A group of hundreds of concerned parents is calling for an immediate halt to a taxpayer-funded study on transgender youth where the young participants are given powerful hormone blockers to stave off puberty and later a regimen of cross-sex hormones.
The Kelsey Coalition, a grassroots organization of parents whose children identify as transgender but who believe current transgender therapy has seriously harmed their children, sent a letter last week outlining their concerns to Dr. Jerry Menikoff, Director of the Office for Human Research Protections, which is part of Health and Human Services.
“The Kelsey Coalition contends this trial is unethical and violates laws protecting human subjects,” the group said in a statement.
The group said the OHRP confirmed Monday that it will “start a review” of the study.
Four pediatric gender clinics were awarded a $5.7 million grant in 2015 by the National Institutes of Health for the five-year study, “The Impact of Early Medical Treatment in Transgender Youth,” which had 279 participants in the cross-sex hormone cohort and 71 participants in the puberty blocker cohort as of April 30, 2018.
The criteria for whether a child is eligible for hormone treatment appears to be simply that they believe their body does not match the gender they feel they are. The study also does not use a control group.
“Childhood gender dysphoria is not an endocrine condition, but becomes one through
iatrogenic blockade and high dose cross sex hormones,” a group of endocrinologists wrote in a letter to the Journal of Clinical Endocrinology and Metabolism. “The consequences of this gender affirmative therapy are not trivial and include potential sterility, sexual disfunction, thromboembolic and cardiovascular disease, and malignancy.”
The age range of participants is 8 to 20-years-old. In 2017, the age for cross-sex hormones was lowered from 13 to 8-years-old, information Dr. Michael Laidlaw, medical consultant to the Coalition, accessed through a FOIA request.
The researchers proposed recruiting another 60 “youth in the early stages of puberty” for cross-sex hormones, but so far only 19 children in the 8 to 12-years-old category have been added to the study.
“Transgender children and adolescents are a poorly understood and a distinctly understudied population in the United States,” the study states, adding that the project’s purpose is to examine “the physiological and psychosocial outcomes of existing medical treatment protocols for transgender youth with gender dysphoria.”
The four clinics participating in the study are the Children’s Hospital Los Angeles in conjunction with the Keck School of Medicine, the UCSF Benioff Children’s Hospital San Francisco, the Lurie Children’s Hospital of Chicago in conjunction with Northwestern University, and Boston Children’s Hospital in conjunction with Harvard Medical School.
“We are pleased to see transgender medicine taking its place on the national health agenda,” said Johanna Olson, MD, medical director of the Center for Transyouth Health at Children’s Hospital Los Angeles. “Results of this study will help physicians across the country provide the best and safest possible care for transgender youth.”