Staff Reports
A clinical investigator for an off-label drug used to treat puberty in trans-identified adolescents raised concerns about the drug's safety.
Marc Garnick, a professor at Harvard and the co-principal investigator of the drug Lupron, criticized the New York Times for its investigation into the side effects of puberty-blocking drugs on adolescents.
Garnick noted that the article, which was based on well-studied research, raises significant concerns about the safety of using puberty-blocking drugs in children and adolescents.
One of the four letters that Garnick wrote was accepted as a response to the article, which detailed the side effects of puberty-blocking drugs on adolescents. The other three letters criticized the article as transphobic.
Garnick was one of the three clinical investigators who helped the FDA approve Lupron for treating advanced prostate cancer. For more than four decades, he had been studying the side effects of GnRH agonists, which include puberty-blocking drugs.
The FDA has approved GnRH agonists to treat endometriosis, juvenile delinquent puberty, and prostate cancer. These conditions are caused by the dysfunction of the pituitary gland, which can cause children to start sexually mature before they reach the age of 8 or 9. Lupron has also been used to castrate sex offenders.
For the treatment of gender dysphoria, doctors have been prescribing puberty blockers off-label. These are not approved for use in this condition, which occurs during a critical phase of development. Most of the published data on the side effects of these drugs only cover the cases of young patients.
In his letter, Garnick noted that doctors are still learning about the safety of puberty-blocking drugs for adults. He also noted that there is a lack of data on the side effects of these drugs for younger patients.
Despite the lack of evidence supporting the safety of puberty-blocking drugs, proponents of gender-affirming care still claim that these medications are safe and can be safely used. GnRH agonists are used to treat various conditions, such as cancer and sexual disorders.
Garnick noted that the use of puberty-blocking drugs in adult men can lead to significant bone loss, as well as a leading cause of morbidity. The New York Times article also noted that the drugs can increase the risk of osteoporosis.
The authors of the article noted that the bone mass of adolescents increases during puberty, which is known to determine their lifetime of bone health. The article also noted that when adolescents are using puberty-blocking drugs, their bone density growth flatlines.
Children who start taking puberty-blocking drugs as early as the first signs of their sexual and fertility development will eventually experience permanent damage.
Garnick also noted that the side effects of puberty-blocking drugs are still being studied. These include cardiovascular, metabolic, and cognitive issues.
The companies that dominate the market for puberty-blocking drugs in the U.S. refuse to carry out safety trials on their drugs, such as Lupron. These are commonly used to treat adolescents with gender dysphoria.
In order to minimize the risks associated with the use of puberty-blocking drugs in children and adolescents, Garnick noted that the guidelines should require that all pre-pubertal and pubertal children be included in studies that are designed to analyze the long-term effects of these drugs.
In Texas, two pharmaceutical companies, Endo Pharmaceuticals and Abbvie, are currently under investigation for allegedly deceiving the public about the safety and effectiveness of their products. The investigation was carried out by the state's attorney general, Ken Paxton.
On the website of drug maker Abbvie, Lupron is indicated for treating various conditions, such as endometriosis, advanced prostate cancer, and uterine fibroids.
On its website, Abbvie states that it supports the LGBTQ+ community and that it aims to "further education around LGBTQ+ issues." The company also noted that it makes donations to various organizations that serve the needs of these groups.
On the other hand, Abbvie is a sponsor of a non-profit organization known as the GenderCool Project, which promotes the concept of trans children. Recently, the company was criticized for partnering with a transgender film called "Mama has a Mustache." According to the company's website, the film, which is about a transgender girl, features audio interviews with kids aged 5 to 10. After Christopher Rufo, the writer of the film, posted a potential conflict of interest on Twitter, the pharmaceutical company was removed from the film's website.
Many people are concerned about the increasing number of adolescents and children adopting a transgender identity. They also worry that these individuals are seeking unnecessary medical procedures. In October, Reuters reported that about 17,683 children between 6 and 17 years old were diagnosed with gender dysphoria and received cross-sex hormones or puberty-blocking drugs from 2017 to 2021. This figure was likely a significant undercount as it only included data from insurance claims.
According to the director of the pediatric division of Boston Children's Hospital, the number of new patients receiving puberty-blocking drugs has increased significantly. Despite the fact that these drugs are known to cause infertility, they still continue to be given to children.
The preceding is a summary of an article that originally appeared on Daily Wire.
