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There is another one that I consider to fall into the category of genuine misconceptions. That is how the HHS review, with the overview as its core evidence base, differs from other reviews, especially the Cass review. I have huge respect for the Cass review team and applaud their systematic review work (on some aspects, I disagree with their approach, and I don’t believe their work is without limitations). But the HHS review is broader because it discusses what the overview cannot tell.
The methodology of evidence-based medicine emphasizes direct evidence, or evidence from human participants, at a group level—what we call “epidemiological evidence.” I am not saying this is wrong, but in some cases, there will be no available epidemiological evidence. The Cass review stops there when it concludes that the evidence is uncertain. Similarly, the overview in the HHS review can only inform us that the evidence of benefit (epidemiological evidence) is uncertain, and at the same time, the evidence of harms is also uncertain. However, “uncertain” is not the same in each case. For benefit outcomes, there are studies, but the results are too biased, so the evidence is uncertain. For potential harms, there are no studies properly assessing these outcomes—Chapter 6 of the HHS review discusses this issue. Then there is Chapter 7, which, together with Chapter 6, goes beyond what Chapter 5 (the overview) can cover. Chapter 7 discusses evidence from biological mechanisms. This approach is not new, but it has not been used in gender medicine. For example, when IARC assesses carcinogens, the methodology does not only consider epidemiological evidence. Rather, it incorporates multiple lines of evidence, considering human-level direct evidence but not discarding our understanding of biology, pharmacology, toxicology, etc.
So, putting Chapters 5, 6, and 7 together, the HHS review provides an answer that the overview alone cannot: the evidence on benefits is uncertain because the available studies are biased, while the evidence on harms is uncertain because there has been no real effort to assess harms—and, based on mechanisms, harms are expected. Again, this approach of considering other lines of evidence is not new; it is common practice in regulation.
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