Trump reverses Biden by opening taxpayer-funded research, scrutinizing 'gender affirming care'
Supporters of puberty blockers, cross-sex hormones and breast removal face another setback with dismissal of lawsuit against Alabama's ban. HHS debuts "universal vaccine platform," requires placebo testing.
The Biden administration politicized the science of treatment for youth gender confusion by hiding taxpayer-funded research that found no improvement in mental health for youth on puberty blockers and by bearing down on a standards-setting group to remove age minimums for so-called gender-affirming hormonal and surgical procedures from a draft.
The Trump administration is pushing back on both fronts, rushing a new policy to immediately make public National Institutes of Health-funded research results and releasing a massive review of youth gender medicine that echoes earlier findings from Europe, which has drastically restricted drugs and surgery for gender-confused youth.
The moves pleasantly surprised administration critics such as University of California San Francisco HIV researcher Monica Gandhi, who has repeatedly intoned against cuts to health research funding but praised NIH Director Jay Bhattacharya for the "extremely fair and good" transparency policy.
Science writer Jesse Singal, who broke the news that transgender Health and Human Services Assistant Secretary Rachel Levine interfered in Standards of Care 8 by the World Professional Association for Transgender Health, said he was shocked the gender medicine review was neither "hackish" nor "authored by cranks."
Coincidentally and ignominiously, the plaintiffs in litigation against Alabama's ban on gender-affirming care for minors, which had accidentally exposed Levine's interference, dropped the case Thursday.
Legal discovery showed "key medical organizations misled parents, promoted unproven treatments as settled science, and ignored growing international concern" over the procedures, said the office of state Attorney General Steve Marshall.
"It is no surprise" they quit, Marshall said.
The plaintiffs, represented by LGBTQ rights groups, emphasized they "secured an initial injunction that blocked the ban temporarily and made a huge difference in people’s lives" despite the case eventually backfiring on them, AL.com reported.
It's been a busy few days for HHS and NIH, which also Thursday announced the National Institute of Allergy and Infectious Diseases was "exclusively" developing a noncommercial "next-generation, universal vaccine platform" for "pandemic-prone viruses" including SARS-CoV-2, MERS-CoV and H5N1 bird flu.
Approved by vaccine-skeptical HHS Secretary Robert F. Kennedy Jr., Generation Gold Standard will use a "whole-virus platform" inactivated by beta-propiolactone.
This preserves "the virus’s structural integrity while eliminating infectivity" across "diverse viral families," without inducing the perennial problem of "antigenic drift" for flu vaccines, HHS said, alluding to the core problem with COVID-19 vaccines from the first Trump administration's Operation Warp Speed: short-lived effectiveness and even negative efficacy.
Kennedy also ordered non-flu vaccine candidates to be tested in placebo-controlled trials going forward, prompting sky-is-falling Washington Post reporting.
An HHS spokesperson reminded similarly alarmist NPR the non-COVID-19 vaccines on the U.S. childhood schedule, which is dramatically larger than in European countries, weren't tested in long-term placebo-controlled trials.
'The grift is over'
The Trump administration's NIH moved up the effective date for the public access policy to July 1 from Dec. 31, 2025, the date set by the lame-duck Biden administration a month before Trump's inauguration. The existing policy, which lets taxpayer-funded researchers withhold their "final peer-reviewed manuscripts" for a year after publication, was set in 2008.
Bhattacharya said the acceleration will "help increase public confidence in the research we fund," citing low public confidence that scientists are working for the common good, "while also ensuring that the investments made by taxpayers produce replicable, reproducible, and generalizable results that benefit all Americans."
"The grift of charging people to read the results of studies they already paid for [as taxpayers] is over" despite the lobbying of medical publishers, former U.S. Right to Know investigator Emily Kopp said. Former Michigan GOP Rep. Peter Meijer called it a "blindingly obvious net-good!"
Some are pressuring NIH to take transparency even further. Rutgers biochemist Richard Ebright said a "more consequential" requirement would be posting research "at the time of submission for journal publication," before it undergoes peer review.
Former Food and Drug Administration regulatory review officer Jessica Adams, who has long chronicled FDA advisory committees, urged Bhattacharya to extend the policy "to all papers authored/co-authored by HHS staff."
'Designed to antagonize' but better than Biden's work
President Trump's sweeping executive order against the "chemical and surgical mutilation of children" in January both prompted the HHS-commissioned review of "Treatment for Pediatric Gender Dysphoria" and seemed to prejudge its findings, as reaffirmed by a White House fact sheet posted two days before the report was made public.
The 409-page report itself, however, earned plaudits from expert journalists including Singal, who gave the issue national visibility with his 2018 Atlantic feature and got caught up in an ACLU subpoena against a gender clinic whistle-blower, and Lisa Selin Davis, who called the U.S. review an improvement on the U.K.'s so-called Cass review.
"Most frustratingly, the Biden administration did not engage in the sort of careful, rigorous evidence evaluation that the Trump administration has, against all odds, published today," Singal wrote for The Dispatch, while scolding the Trump administration for messaging that "seems designed to antagonize" rather than persuade critics of its findings.
Commissioned by the U.K.'s National Health Service, that review by former Royal College of Paediatrics President Hilary Cass had the goal of "improving" pediatric gender medicine even as it spelled the end of medical approaches outside clinical trials, while the HHS review concludes the field can't be fixed, Selin wrote for Unherd.
The evidence of "pediatric medical transition" harm outweighs the evidence of benefit, even as both are uncertain, says the report's chapter on ethics. (Nearly half the report is a single appendix of the reviewed evidence and best practices.)
"When medical interventions pose unnecessary, disproportionate risks of harm, healthcare providers should refuse to offer them" because they increase the risk of treatment-caused harm and reduce "medicine to consumerism," it says.
Even if randomized control trials on puberty blockers and hormones were "feasible," the report says it may yet violate human subjects research ethics because the harm is so certain, such as infertility that naturally follows puberty blockers and hormones. This is akin to an RCT "on the effects of jumping from a plane without a parachute."
It scolds "many U.S. medical professionals and associations" for rapidly expanding "a clinical protocol that lacked sufficient scientific and ethical justification," sticking with it when it failed, ignoring Europe's changes, mischaracterizing or ignoring "conflicting evidence" and marginalizing "dissenting perspectives," ultimately failing their young patients.
The biggest limitation of the U.S. review may be the anonymity of the reviewers, justified by HHS to "help maintain the integrity of this process." The analysts behind a private review of abortion pill complications from a massive insurance database similarly hid their identities.
HHS said each chapter went through peer review "and a post-publication peer review will begin in the coming days involving stakeholders with different perspectives."
Singal said HHS identified the nine reviewers to him off the record. He recognized them as "informed skeptics who have been deep in the weeds" on youth gender medicine, a "significant number" of whom have published peer-reviewed papers on it.
The authors fear "threats and other reprisals" if identified, according to the U.K. Times. A source "close to the process" said some of the authors "don't support Trump" but the worst choice was "allowing this field of medicine to go completely unregulated and see kids sterilised and have breasts amputated with zero accountability."
The Facts Inside Our Reporter's Notebook
Videos
Links
- hiding taxpayer-funded research that found no improvement
- bearing down on a standards-setting group to remove
- massive review of youth gender medicine
- repeatedly intoned against cuts to health research funding
- praised NIH Director Jay Bhattacharya
- Jesse Singal, who broke the news
- Rachel Levine interfered in Standards of Care 8
- neither "hackish" nor "authored by cranks."
- dropped the case Thursday
- Attorney General Steve Marshall's office said
- AL.com
- "exclusively" developing a noncommercial "next-generation, universal vaccine platform"
- "antigenic drift" for flu vaccines
- short-lived effectiveness and even negative efficacy
- Washington Post
- similarly alarmist NPR
- dramatically larger than in European countries
- long-term placebo-controlled trials
- NIH moved up the effective date
- Biden administration a month before Trump's inauguration
- withhold their "final peer-reviewed manuscripts" for a year
- low public confidence that scientists
- Emily Kopp said
- Peter Meijer called it
- Richard Ebright said a "more consequential
- long chronicled FDA advisory committees
- extend the policy "to all papers authored/co-authored by HHS staff."
- "chemical and surgical mutilation of children"
- "Treatment for Pediatric Gender Dysphoria"
- White House fact sheet posted two days before
- 409-page report
- 2018 Atlantic feature
- ACLU subpoena
- spelled the end of medical approaches
- Selin wrote for Unherd
- single appendix of the reviewed evidence and best practices
- justified by HHS
- abortion pill complications from a massive insurance database
- Times