Texas AG Paxton investigates pharma companies over puberty blockers in trans kids: 'child abuse'
The FDA has not approved these drugs for gender dysphoria
{{#rendered}} {{/rendered}}Texas Attorney General Ken Paxton announced an investigation into two pharmaceutical companies that allegedly promoted hormone-blocking drugs for children with gender dysphoria, even though the drugs have not been approved for this purpose. One of the companies told Fox News that it has not promoted the drugs for gender dysphoria.
"Puberty blockers used on minors experiencing gender dysphoria or similar mental disorders is child abuse," Paxton told Fox News in a statement Wednesday. "Doctors, parents, guardians, and counselors who aid and abet the use of puberty blockers in an improper manner are complicit in the abuse. As are prescription drug manufacturers, which is the basis of my investigation."
"Everyone involved in damaging our young people like this must be held accountable and brought to justice, and that's exactly what I'm doing," he added.
{{#rendered}} {{/rendered}}TEXAS SUES BIDEN ADMIN TO BLOCK TRANSGENDER MANDATE ON PRONOUNS, DRESS CODES, BATHROOMS
Paxton opened an investigation into the companies Endo Pharmaceuticals and AbbVie Inc., seeking to determine whether they violated the Texas Deceptive Trade Practices Act. They allegedly advertised and promoted hormone blockers for "unapproved uses without disclosing the potential risks associated with these drugs to children and their parents."
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Supprelin LA and Lupron Depot have been approved for treating children with Central Precocious Puberty (CPP), when the puberty process begins prematurely. Doctors have prescribed Vantas, along with other forms of Lupron, as a palliative for prostate cancer. The Food and Drug Administration (FDA) has not approved these drugs to treat gender dysphoria, which Paxton's office describes as "a diagnosed mental disorder in which a person experiences significant distress related to a strong desire to be of another biological sex."
{{#rendered}} {{/rendered}}Endo Pharmaceuticals denied promoting these drugs for gender dysphoria.
"Endo Pharmaceuticals Inc. manufactures and markets Supprelin® LA for the treatment of children with central precocious puberty (CPP)," Heather Zoumas Lubeski, a spokeswoman for the company, told Fox News. "Vantas®, indicated for the palliative treatment of advanced prostate cancer, was discontinued due to manufacturing issues and has not been a promoted product for more than five years."
Ken Paxton, Texas attorney general, speaks during a news conference outside the Supreme Court in Washington, D.C., U.S., on Monday, Sept. 9, 2019. A group of 50 attorneys general opened a broad investigation into whether advertising practices of Alphabet Inc.'s Google violate antitrust laws. Photographer: Andrew Harrer/Bloomberg via Getty Images (Photographer: Andrew Harrer/Bloomberg via Getty Images)
"The company has not promoted either of these medications outside of their indications and does not promote medications for off-label uses," Zoumas Lubeski added. "That being said, we intend to fully cooperate with this inquiry/investigation."
{{#rendered}} {{/rendered}}"We do not have any approved medications indicated for gender dysphoria and we do not promote medications for off-label uses," the spokeswoman added.
AbbVie did not respond to Fox News' request for comment by press time.
"I agree with AG Paxton that these drugs are only FDA approved as puberty blockers in children for the purpose of treating central precocious puberty and not for gender dysphoria," Dr. Michael Laidlaw, an independent private practice endocrinologist in Rocklin, Calif., told Fox News.
{{#rendered}} {{/rendered}}"Central precocious puberty is a medical condition in which a child starts puberty at an abnormally young age, say age 4," Laidlaw explained. "Medications like Supprelin LA are used to stop this abnormal puberty. Then once the child reaches a typical age for puberty (say age 11 or 12), the medication is stopped, and then normal puberty will resume."
A gender-neutral bathroom is seen at the University of California, Irvine in Irvine, California. (Reuters/Lucy Nicholson)
"The off-label use of these medications for gender dysphoria is completely different," the endocrinologist added. "In this case the healthy child has already begun normal puberty. But then the medication is given to block normal puberty. Blocking normal puberty has numerous unhealthy side effects including loss of normal bone development, interference with normal brain and social development, and importantly causes infertility and sexual dysfunction. Many of these effects will be irreversible."
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{{#rendered}} {{/rendered}}He also noted that the medications are "very expensive." Supprellin LA is a surgically-implanted device that slowly releases the medication over about a year. One 50mg subcutaneous implant of the drug costs about $44,973. Laidlaw said that one parent told him the bill from the hospital for the procedure and the medication device ran about $210,000.