FDA releases records about ‘Gender-Affirming Care and Young People’ document promoting puberty blockers

FDA (Image: Wikimedia)

Earlier, a Freedom of Information lawsuit I filed revealed that HHS promoted gender transitions for minors without consulting with key experts at the FDA. The FDA has warned that the puberty blockers used by minors in gender transitions can have dire side effects, such as brain swelling and permanent vision loss.

While HHS did not consult FDA before promoting puberty blockers and other controversial treatments, records now reveal that the public did ask the FDA questions about HHS’s actions. FDA referred such a query to the HHS; the FDA apparently received no substantive reply. Those records which were released on September 1, are found at this link.

An email contained in those records asked the FDA’s press office:

In March, the Department of Health and Human Services Office of Population Affairs (HHS/OPA) issued a guidance document called Gender-Affirming Care in Young People. The document claims to outline an established standard of care on how to proceed with social, pharmacological and surgical “affirmation” of children and adolescents who identify as transgender. When announcing the new document, Assistant Secretary for Health Rachel Levine claimed, “there is no argument among medical professionals—pediatricians, pediatric endocrinologists, adolescent medicine physicians, adolescent psychiatrists, psychologists, etc.—about the value and the importance of gender-affirming care.”

However, puberty blockers and cross-sex hormones for gender transition are all off-label, non-FDA-approved uses.

What published studies were the basis for the HHS/OPA recommendations regarding the use of those drugs? Were existing FDA- and non-FDA drug safety databases reviewed to assess risk to gender-appropriate and gender-incongruent application and administration? Was anyone from the FDA consulted on these recommendations? If not, why not?

The document does not discuss any potential short- or long-term risks of its pharmacological and non-pharmacological recommendations, or any shortcomings, disadvantages or alternatives to the various proposed treatments and procedures. Are there any such risks?

The document refers exclusively to psychological sources. But it makes no recommendation for any psychological evaluation or criteria prior to patients’ undergoing life-altering interventions.

Should there be a waiting or evaluation period prior to a pharmacological or surgical intervention? According to its mission statement, HHS/OPA focuses on family planning, teen pregnancy and adoption, so why is it even commenting on gender transition treatments? Why not leave the pharmacological issues to the FDA?

While the document does include citations to specific studies, they only consist of psychology studies—no pharmacological, genetic, medical, surgical, gynecological, or endocrinological studies. Is there a reason for this? Did HHS/OPA review any pharmacological, genetic, medical, surgical, gynecological, or endocrinological studies in drafting these recommendations? What pharmacological, medical, gynecological, or endocrinological evidence did it rely on?

When FDA’s Thanh Nguyen-Chu forwarded this query to HHS’s Office of Population Affairs, it did not address the substance of this email, or tell FDA how to reply to it. It just said,

Good afternoon Thanh Nguyen-Chu,
Thank you for sharing this message. Confirming receipt.
Office of Population Affairs
Health Communications and Partnership Engagement Team
U.S. Department of Health and Human Services

There is no indication thus far that HHS replied to the member of the public who sent this email. FDA apparently did not. If HHS did, I will likely found out by early October, because HHS says it is searching its records for such emails, expects to complete its search by September 9, and expects to produce its first batch of records to me by October 9.

HHS apparently did not discuss the document promoting gender transitions for minors (“Gender-Affirming Care and Young People”) with FDA before issuing it. On August 9, 2022, the FDA issued its response to a Freedom of Information request seeking such records, stating that “A search of the Covered FDA offices did not locate responsive records; therefore, we have no documents to provide you.” FDA would have such records, if HHS or its Office of Population Affairs had sent drafts of the “Gender-Affirming Care and Young People” document to experts at the FDA for their review. But according to the letter sent to me by Meredith J. Schlaifer of FDA, no such records exist.

In March 2022, the Department of Health and Human Services issued that document promoting gender transitions for young people, including “puberty blockers” “during puberty”, “hormone therapy” from “early adolescence onward”, and “gender-affirming surgery” (such as removal of breasts and testicles) either in “adulthood or case-by-case in adolescence.”

Strangely, this HHS guidance document, titled “Gender Affirming Care in Young People,” was issued not by HHS agencies that have expertise in transgender issues (such as the Food and Drug Administration, which regulates drugs such as puberty blockers), but rather by the Office of Population Affairs, which deals with family planning, teenage pregnancy, and adoption.

In Newsweek, former FDA official David Gortler expressed concern about this, and asked why the Office of Population Affairs was “even commenting on gender transition treatments….As a former senior executive FDA drug safety official, I have to wonder why my 20,000-plus former colleagues at the FDA are not speaking out after being circumvented on transgender clinical pharmacology recommendations by an obscure, obviously unqualified HHS office.”

The FDA recently added a warning to the puberty blockers used by transgender children undergoing gender transitions. The warning was added after the FDA identified “a serious potential side effect” that can “cause a dangerous surge of spinal fluid pressure in the brain,” as well as “headaches, nausea, double vision, and even permanent vision loss.”

As Gortler noted in Newsweek, the HHS “gender affirming care”

document claims to outline an established standard of care on how to proceed with social, pharmacological and surgical “affirmation” of children and adolescents who identify as transgender. When announcing the new document, Assistant Secretary for Health Rachel Levine went so far as to state “there is no argument among medical professionals—pediatricians, pediatric endocrinologists, adolescent medicine physicians, adolescent psychiatrists, psychologists, etc.—about the value and the importance of gender-affirming care.”

Levine’s extreme statement was rightly rebuked by physicians and members of Congress for not being appropriately based in evidence.

At first glance, the HHS/OPA document gives the impression that anyone and everyone should just start writing prescriptions and scheduling surgical procedures upon request. Observant scientists and clinicians will notice the document is most remarkable for what it doesn’t say.

As a pharmacologist, pharmacist and research scientist who has dedicated his life to drug safety, drug development and evidence-based clinical and non-clinical science and medicine, I have some important questions—starting with who the authors of this document are, and what academic credentials they have.

Puberty blockers and cross-sex hormones for gender transition are all off-label, non-FDA-approved use. I’d be curious what published studies were the basis for the HHS/OPA recommendations regarding the use of those drugs. Were existing FDA- and non-FDA drug safety databases reviewed to assess risk to gender-appropriate and gender-incongruent application and administration? More importantly, was anyone from the FDA even consulted, and if not, why not?

The document fails to mention the potential short- or long-term risks of its pharmacological and non-pharmacological recommendations.

Gortler was right. The experts at the FDA were apparently not even consulted by HHS’s leadership or the Office of Population Affairs before HHS issued this document promoting gender transitions for minors.

We now know this because after I read Gortler’s article in Newsweek, I submitted requests under the Freedom of Information Act (FOIA) for communications between FDA and HHS about the drafting or content of the Gender-Affirming Care and Young People” document. On August 9, 2022, the FDA issued its response, stating that “A search of the Covered FDA offices did not locate responsive records; therefore, we have no documents to provide you.” FDA would have such records, if the Office of Population Affairs or HHS had sent drafts of the “Gender-Affirming Care and Young People” document to experts at the FDA for their review. But according to the letter sent to me by Meredith J. Schlaifer of FDA, no such records exist.

FDA’s Elizabeth Teter subsequently disclosed that in fact, records do exist, for one type of record that I requested: Communications between the public and the FDA about “Gender-Affirming Care and Young People.” 16 pages of such records were released to me on September 1. But FDA still says there were no communications between it and HHS about the drafting of “Gender-Affirming Care and Young People.”

My May 25 FOIA request to FDA was submitted on behalf of the Bader Family Foundation and the Liberty Unyielding blog. As FDA notes, I requested

1. All communications between March 1, 2022, and the date you process this request, with covered FDA offices about “Gender-Affirming Care and Young People,” a guidance document issued by the Office of Population Affairs in the Department of Health and Human Services dated March 2022.
2. All communications between February 1, 2022, and March 31, 2022, with covered FDA offices about the drafting or content of “
Gender-Affirming Care and Young People.”

I submitted a similar (but not identical) FOIA request to the HHS on behalf of the Foundation and this blog. The agencies’ responses to my FOIA requests were due on June 24, 2022, twenty working days after I submitted the requests.

When FDA and HHS failed to comply with that legal deadline, the Bader Family Foundation sued them on July 19, 2022, filing a complaint in the U.S. District Court for the District of Columbia, where the lawsuit remains pending. The lawsuit forced the FDA and HHS to respond to my FOIA requests.

For your convenience, you may leave commments below using Disqus. If Disqus is not appearing for you, please disable AdBlock to leave a comment.



Source link

By GIL