National Institutes of Health funds $5.7 million grant to study pediatric transition

This is big news. Children who have been diagnosed as “transgender,” who are currently being experimented on with hormones and surgeries, will finally be studied in (one hopes) a systematic way at several clinics across the U.S. over a 5 year period.

The good news? Someone will actually be collecting data and publishing research studies on these kids. The bad? The children are still the same guinea pigs, being treated experimentally with outcomes still to be determined.

The studies will run for 5 years, which will be enough time to yield some important information. But the real litmus test is what life will be like for these children when they grow up to be adults.  The younger children will still be adolescents when the studies end. One can only hope that the NIH will fund further longitudinal studies to follow these people–some of whom will be permanently sterilized–well into their lives as adults.

The study – which will begin enrollment in fall 2015–will include 280 transgender youth with gender dysphoria–those who are persistently distressed by the incongruity between their gender of identity and the gender they were assigned at birth. Participants will be those who seek medical intervention to align their physical bodies with their gender identity and alleviate gender dysphoria and its associated negative effects, including anxiety, depression and substance abuse.

The study will include youth from two age groups: younger children in early puberty, who will receive hormone blockers, called GnRH agonists, used to suspend the process of puberty – preventing the development of undesired secondary sex characteristics; and older adolescents, who will begin use of masculinizing or feminizing cross-sex hormones that allow them to go through the ‘right’ puberty – consistent with their gender of identification.

For the cohort in the earliest stages of puberty, the study will evaluate the impact of treatment on mental health, psychological well-being, physiologic parameters and bone health, and will document the safety of hormone blockers. In the older group, the study will document the safety of administering cross-sex hormones for phenotypic gender transition, as well as evaluate its impact on mental health, psychological well-being, and certain metabolic/physiological parameters.

Who will be conducting this NIH-funded research? The doctors who have made the biggest names for themselves in the new frontier of pediatric transgender “treatment”:

The multicenter study will be located at four academic medical centers with dedicated transgender youth clinics. The co-investigators and their institutions include:

Johanna Olson, MD, Children’s Hospital Los Angeles and the Keck School of Medicine of the University of Southern California

Stephen Rosenthal, MD, UCSF Benioff Children’s Hospital San Francisco

Robert Garofalo, MD, MPH, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine

Norman Spack, MD, Boston Children’s Hospital and Harvard Medical School

These doctors have a lot at stake to prove that their experimental treatments will produce positive longterm outcomes for these kids–over the lifespan. Can and will they design studies that will truly be unbiased and well controlled? Will they end the studies and treatments early if negative outcomes start piling up? Will they be motivated to apply for more funding after 5 years, or will they declare 16-year-olds who began transitioning  at 11 successes and cease following them? Will they look closely at how natal males and females differ in their response to hormones and surgeries?

Time will tell. For the children’s sake, we can only hope these doctors will use the NIH research money ethically and wisely.

But given how much these doctors have already invested in administering hormones to kids and publicly touting the unmitigated good of “transition” and “trans kids,” it’s hard to see how they can approach this research without bias. If long-term evidence ultimately shows more harm than good resulting from this, they will be seen as providers who hurt innocent children–a much bigger stigma than harming adults.

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22 thoughts on “National Institutes of Health funds $5.7 million grant to study pediatric transition

  1. Evidence quality from a single-arm (no comparator) observational cohort, n=280, will be approximately worthless. This will be a study designed to confirm their narrative. There will surely be lots of peer-reviewed papers reporting early “happy” results and far fewer papers as the kids get older and run into difficulties.

    Already in the press release they invoke the term “evidence-based,” to create an impression that the study would provide high quality evidence. This is going to be crap quality evidence, chock-full of bias and random error. However, Spack and his perverted doctor pals who have been “salivating” to “get their hands dirty” will continue to put their best lying “spin” on all results.

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  2. There is no way that study will be objective! These are doctors invested in the ‘right’ outcome, financially and otherwise. If the methods are self-reporting and they know how to phrase questions, it’s a foregone conclusion. Plus it’s a small group and the five year cut off point will give them the best results, way before the full impact will become apparent to the participants. It will be a study in confirmation bias.

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  3. I saw the list of investigators and my heart sank. I don’t know how they will ever find the results other than those that they are seeking. The real results will be reported by the subjects themselves in 10-20 years time.

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    • Unfortunately, this is really typical in clinical research. People who are doing the “treatments” are the ones who apply for, and receive, NIH funding. Cherry picking the data and extreme bias on the part of these doctors will be a real issue. And my biggest problem is the 5-year time length too (as well as the small number of subjects). No way will we know the true long-term effects of hormones, surgeries, and psychological impacts in 5 years. Most will still be kids when the studies end. I hope someone is planning to follow them much, much longer.

      I have a small glimmer of hope, because at least someone will be collecting data. And we can hope NIH will be expecting decent controls and rigorous peer review. But they shouldn’t be experimenting on these kids in the first place. Studying them after the fact is (barely) better than nothing…

      Liked by 1 person

  4. I wouldn’t call this “corrupt” exactly. As 4thwave notes, this is usually the way it happens. NIH can only review the applications that it gets; applications undergo peer review; the people in the best position to recruit and test subjects are the clinicians giving the treatments. But I’d be a lot happier if this project had an independent psych person as a co-investigator.

    That said, the controls on NIH research are pretty good. You have to document consent of every participant, they have to consent at every meeting you have with them, and you have to report how many people have dropped out or been lost to followup. You have to report any harms to your Institutional Review Board, the group who make sure that people are treated ethically. So it would be hard to conceal if, for example, unhappy people dropped out. The consequences of outright fraud would be catastrophic, as would failure to publish at all. Of course, the system can and does break down, and could here, but we can realistically hope that it won’t.

    It will be absolutely essential to read the published research articles from this group in the original, in full. Undesired results can be hidden in plain sight. They have to be reported in the Results section (which will be highly technical and hard to read), but may be left out of the abstract, which is the paragraph-long summary that shows up in PubMed even if the full paper is paywalled. They can even be ignored in the discussion section of the original paper – peer review should catch that, but doesn’t always.

    You can count on it that results will be spun in press releases, and that anything in the popular press will be absolutely worthless.

    You can see what research is being funded here:
    http://projectreporter.nih.gov/reporter.cfm
    There are a couple of other studies relevant to trans issues, but I haven’t had a chance to look at them yet.

    Liked by 1 person

    • Yes, the good thing about this being a major NIH grant, as opposed to some rinky-dink little self generated study, is that there are rigorous requirements and checks and balances. Doesn’t mean they aren’t coming to the work with a giant confirmation bias, of course. But like Olaru says, the National Institutes of Health have very strict standards about how taxpayer-funded research is conducted. Those standards can’t do anything to protect these kids right now, but at least for the first time they are going to be tracked and studied.

      Liked by 1 person

    • Great link, olaru, thank you! It readily turned up the specific NIH RePORT database entry for the Olson, Rosenthal et al. project: http://projectreporter.nih.gov/project_info_description.cfm?aid=8965408&icde=25810400

      Not a great deal behind the gray tabs there yet, of course, but the Similar Projects tab does provide an interesting list of studies in progress elsewhere on related subjects. And behind the Details tab, the entry states researchers applied under Funding Opportunity Announcement (FOA) PA-12-111, which is also online: http://grants.nih.gov/grants/guide/pa-files/PA-12-111.html

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  5. One more point: Five years may be the maximum they could get funded. I would expect them to apply for funding to continue their research if the first years of the project are successful, that is, generate publications in peer-reviewed journals.

    Liked by 1 person

  6. We don’t need a study to know that sterilizing children is a human rights abuse. So, the federal government is going to allow children to be intentionally sterilized with GnRH agonists and/or cross gender hormones. Then, they are going to decide whether it’s a good thing or not. How can sterilizing children ever be a good thing?

    Liked by 2 people

  7. I’m struggling to understand this. So, the federal government is going to let children be intentionally sterilized with GnRH agonists and/or cross gender hormones. They are already doing this, but now they have to do some kind of official biased b.s. “study”. How can sterilizing children ever be a good thing? It’s a human rights abuse. This is just an attempt to cover their asses when it all comes tumbling down. They can say, “Well, such and such says…” I’m not buying it.

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  8. sorry, premature clickage…. what I meant to say is, i agree that 5 years is way too short a time. I have to hope there will be extensions. But we’ve been calling on these folks to do research, so some is a lot better than none. There are only so many times you can say, “I hope someone does research on the treatment I am providing based on almost no research” without losing all your credibility. IMO.

    To be really useful of course it’d need to be stacked against a control group of gender dysphoric minors who don’t get the blockers/hormones treatment but rather some more conventional psych work. Not ‘conversion therapy’ or ‘reparative therapy’ but just investigational work to tease out what factors might be on the table outside the gender essentialist view. Without looking at that group, half the key data is missing. (Though of course there are those who’d say that depriving gender dysphoric kids of this regime is tantamount to murder, and thus unethical. I obviously would not be among those who’d say that. )

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