A $10 million study on the mental health effects of puberty blockers in transgender youth has become a focal point in the ongoing debate over gender-affirming care in the United States. Dr. Johanna Olson-Kennedy, a prominent advocate for transgender rights and the study’s lead researcher, has chosen to withhold the results, citing concerns that the findings could be used against gender-affirming care for children. This decision has sparked criticism from both fellow researchers and opponents of puberty blockers, who argue that withholding the study is contrary to scientific standards.

The National Institutes of Health (NIH)-funded study, which began in 2015, tracked 95 children, with an average starting age of 11, as they received puberty blockers—medications designed to delay the onset of physical changes during puberty. After two years, the study found that the mental health of the children had not improved as a result of the treatment. Olson-Kennedy explained in an interview with The New York Times that the participants’ mental health was relatively stable before and after treatment, attributing the lack of significant change to the children being “in really good shape” mentally from the outset.

However, this finding contradicts earlier data gathered by the study, which indicated that roughly 25% of participants experienced symptoms of depression or suicidal thoughts before starting treatment. The decision not to publish has raised questions about scientific transparency and integrity, particularly in a field where public opinion is sharply divided and access to reliable data is critical.

Critics argue that withholding research results due to concerns over their potential misuse sets a dangerous precedent. Amy Tishelman, a clinical and research psychologist who was involved in the study, told The New York Times that while she understands the fear of data being “weaponized,” the results should be made public. “No change isn’t necessarily a negative finding—there could be a preventative aspect to it,” she said, emphasizing the need for further investigation.

Erica Anderson, a clinical psychologist and expert on transgender youth, expressed her dismay, calling the decision “shocking” and “disturbing.” She argued that it is the responsibility of researchers to share their findings, regardless of the potential backlash, noting that “it’s not her prerogative to decide based on the results that she will or won’t publish them.”

Olson-Kennedy’s decision is rooted in concerns about how the study’s results could be used in legal battles against gender-affirming care for minors. She noted that critics might leverage the findings in court cases to challenge the use of puberty blockers, especially as more than 20 states have passed bans or restrictions on such treatments in recent years. Olson-Kennedy emphasized the need for a careful and thorough analysis before releasing the study, saying, “It has to be exactly on point, clear and concise. And that takes time.”

This delay has drawn criticism from those who believe that research should be released without bias, with the aim of fostering informed debate. Opponents of withholding the data argue that the results could contribute to a more nuanced understanding of the effects of puberty blockers and help inform future medical decisions.

The controversy around the study comes amid a broader international reevaluation of puberty blockers and gender-affirming care. England’s National Health Service (NHS) recently limited the use of puberty blockers for minors, following a review that found the evidence for their benefits was limited. Similarly, Finland’s leading pediatric gender medicine expert, Dr. Riittakerttu Kaltiala, has advised caution, stating that a majority of gender-questioning children eventually come to accept their bodies without the need for medical intervention.

In contrast, the 2011 Dutch study, which has served as a cornerstone for advocating puberty blockers, found that the treatment led to improved mental health and reduced emotional distress in transgender youth. The differing outcomes between the Dutch research and Olson-Kennedy’s study underscore the complexities of this evolving field.

With the scientific and medical community divided over the best approach to treating gender dysphoria in children, many stress the need for open access to research findings. Transparency in studies like Olson-Kennedy’s is seen as crucial for developing an evidence-based understanding of how best to support transgender youth. “We’re craving information about these medical treatments for gender-questioning youth,” Anderson said, adding that releasing such data helps ensure that the care provided is rooted in the best available science.

While Olson-Kennedy’s concerns about the potential misuse of the study’s findings are understandable, critics argue that the decision to withhold the data undermines the values of scientific integrity and public trust. As debates about gender-affirming care continue to unfold across the country, the need for clarity, honesty, and evidence has never been more pressing.

An audit conducted by the inspector general for the Department of Health and Human Services (HHS) has confirmed that the Food and Drug Administration (FDA) mishandled the 2022 infant formula crisis, exacerbating the situation, according to a House GOP panel chairperson.

Audit Findings and Congressional Response

Rep. Lisa McClain, chairwoman of the Food and Drug Subcommittee on Health Care and Financial Services, announced on Monday that the long-awaited audit substantiates findings by the House Oversight Committee. “The 2022 nationwide infant formula crisis was exacerbated by dysfunction and delay within the FDA,” McClain stated.

The audit highlights critical failures within the FDA, including its failure to heed whistleblower warnings, conduct adequate inspections, and respond swiftly to the unfolding crisis. These shortcomings, according to McClain, had “serious implications” for the availability of infant formula across the nation.

Details from the Audit

The inspector general’s audit provides a detailed examination of the FDA’s actions and inactions during the crisis. Key points from the audit include:

• Ignored Whistleblower Warnings: The FDA reportedly failed to act on early warnings from whistleblowers within the industry who flagged potential issues with formula production and safety.
• Inadequate Inspections: The audit found that the FDA did not conduct timely and thorough inspections of formula manufacturing facilities, which could have identified and mitigated risks earlier.
• Slow Responsiveness: The FDA’s delayed response to emerging problems contributed significantly to the crisis, affecting the supply chain and availability of infant formula nationwide.

Implications and Accountability

Rep. McClain emphasized the serious implications of the FDA’s mishandling, which resulted in widespread shortages and panic among parents. She noted that multiple former FDA officials had testified before the subcommittee, corroborating the audit’s findings and shedding light on the agency’s internal failures.

“We are going to continue to use the tool of oversight to ensure that the FDA implements the recommendations in this report,” McClain said. She stressed the importance of the FDA making necessary adjustments to their policies and procedures and holding affiliated parties accountable for their roles in the crisis.

Future Actions

The subcommittee, led by McClain, plans to closely monitor the FDA’s implementation of the audit’s recommendations. The goal is to ensure that the agency adopts more effective practices and policies to prevent similar crises in the future. “This audit is a crucial step in understanding what went wrong and how we can fix it,” McClain added.

The findings of the HHS inspector general’s audit serve as a critical reminder of the need for vigilant oversight and accountability within federal agencies, particularly those responsible for public health and safety. The House GOP panel, under McClain’s leadership, aims to push for reforms that will restore confidence in the FDA’s ability to manage and mitigate such crises effectively.

The full report by the inspector general is expected to be a cornerstone for future legislative and administrative actions aimed at bolstering the FDA’s operational efficiency and responsiveness.

Controversy surrounding the handling of transgender treatments for minors has reached new heights as Dr. Eithan Haim, a surgeon-turned-whistleblower, faces a four-count indictment for HIPAA violations. Haim attended his initial appearance in Texas federal court on Monday after his indictment for allegedly obtaining and accessing sensitive information of pediatric patients in the Texas Children’s Hospital system without authorization.

According to the indictment announced by U.S. attorney Alamdar Hamdani, Dr. Haim is accused of accessing the personally identifiable information of pediatric patients in the Texas Children’s Hospital system without authorization. The indictment stems from Haim’s leak of documents last year, revealing that the hospital continued to conduct transgender procedures on minors, despite claiming to halt such procedures the year before. This information came to light following Texas attorney general Ken Paxton’s non-binding legal opinion equating transgender treatments with child abuse and Governor Greg Abbott’s subsequent order for a state investigation into gender-affirming care.

Prosecutors, led by assistant U.S. attorney Tina Ansari, claim that Dr. Haim obtained the sensitive patient records under false pretenses and intended to cause malicious harm to Texas Children’s Hospital. They argue that his actions violated the Health Insurance Portability and Accountability Act (HIPAA), which protects patient confidentiality and grants limited exceptions for reporting egregious medical misconduct.

Dr. Eithan Haim claims the documents he leaked to journalist Christopher Rufo were redacted to protect patient identities, asserting that HIPAA permits disclosure to stop serious medical misconduct. Rufo confirmed that critical details were redacted. Haim, then a resident at Baylor College of Medicine, is also accused of reactivating his login to access records of patients not under his care.

If convicted, Haim faces up to ten years in prison and a $250,000 fine. The case is being prosecuted in the Southern District of Texas. Haim learned of the indictment on June 4, when armed U.S. marshals arrived at his home, which he described as an intimidation tactic. He insists that his actions were in line with his professional duty to expose misconduct at Texas Children’s Hospital.

Haim plans to fight the charges to set a precedent for future whistleblowers, rejecting any plea deal. Legal costs have already exceeded $250,000, but donations on his GiveSendGo page have surpassed $620,000, with a goal of $1 million. Haim is determined to clear his name in the forthcoming trial.