This is a fantastic summary of McMastergate, if we can call it that. This is the thing people should read BEFORE Jesse Singal's piece, which goes into a greater depth that not everyone will want.
There have been 2 testosterone products submitted to the FDA for approval and both were denied. A patch and a gel dosed at ~10% of the male dose. Both had been tested in RCTs for female sexual dysfunction in postmenopausal women. The patch showed very modest benefit and the gel wasn't significantly different vs. placebo for the primary endpoint but showed (small) improvements in some secondary endpoints. More acne and hair growth with T but no increase in severe adverse effects. The trials were short (12-24 weeks), were too small to detect rare serious adverse effects, and had high rates of attrition. The FDA's main concern was the lack of long-term safety data. They didn't say women and their doctors should decide - they would not let these products enter the market because there was potential for severe harm.
But here we are with the father of EBM saying we should let children(!) engage in shared decision making about taking testosterone dosed to achieve serum concentrations >6 x the normal female range, and typically lifelong.
"They atoned, and they tithed. They stopped acting like scientists, and instead acted like sinners." Yup pretty much sums up most of the "scientist" currently in this mess!
Thank you for this clear, well-presented explanation not only of what happened here, but also of the all-important larger context. Your closing paragraph is pitch perfect.
Does the father of evidence based medicine not realize that you cannot call something "medically necessary" if there is only low quality evidence that it does what it claims to do, along with mounting stronger quality evidence that it causes harm, not to mention regret?
They only talked about low certainty of benefits in their letter.
Medical decision making involves benefits, risks, alternatives and doing nothing.
If the evidence has low certainty of benefit and high certainty of harm, for instance, then one makes a *strong* recommendation to not do the intervention.
And:
"When low quality evidence suggests equivalence of two alternatives, but high-quality evidence of less harm for one of the competing alternatives" the recommendation is "Strong recommendation for less harmful/less expensive"
The transcript of Jesse Singal's interview of Guyatt is remarkable. Take Lisa's advice and read it . . . Guyatt's inconsistent statements and claims to be too busy whenever Jesse mirrored back his more ridiculous ones and his veiled threats to end the interview . . . just so obviously a guy unwilling to face up to his own hypocrisy and cowardice or the reality that he's dependent on an institution that does not respect and will NOT protect intellectual freedom or the integrity of science. Perhaps what he was subjected to at that hands of colleagues and administrators at McMasters shocked him, and he's in denial. These things became very clear to me: He's not invulnerable; he does have a price (just like any garden-variety sophist . . . or intellectual whore); and he doesn't seem to have encountered (yet) anyone who can get him to admit it.
He's clearly been subjected to several struggle sessions. In his defense, he seems much more concerned about the careers of his junior colleagues and students, which is appropriate and commendable.
It sure doesn't make the sciences look good. Sad that they're no more sensible than your average seminar on post-structuralist philosophy or women's studies--but with major real-world costs for trans-identified kids and young people as well as their families.
How is patient autonomy possible if patients remain uninformed (or even disinformed) about the risks and outcomes?
This episode may be another illustration of why "science" isn't going to get us out this mess. As you note, Lisa, there is a much larger context around what happens in the medical facilities. It's that context (the ideology, the affirmation by authorities, the social approbation) that feeds people into medicalization.
I hope he reads your piece, Lisa. You make great points. It seems to me that he (like most) really can't handle the idea that his friends and family just don't want him to appear to be on this side of the issue. And the younger researchers are rightly freaked out given how they've been treated by activists. I disagree that he had some "added responsibility" with how the SRs are used. You can't control what others do with it.
Re Guyatt's motives, it seems to me that a big one is that he doesn't like non-physicians (eg state legislatures) exerting authority on a medical issue over physicians. That usurpation (as he sees it) of physician authority greatly annoys him, and the transqueers got him to believe that his SRs were contributing to it.
In light of the scandals emerging in the coverage of the mass school shooting in Minneapolis, in which a male formerly Robert, recently right before coming of age, Robin went off his rocker and killed Catholic school children at prayer in the church adjacent to the school. Then he killed himself, after making sure his manifesto was already out there on his youtube channel. The over-representation of violent males in the ranks of patients who call themselves "trans women" will eventually be covered somewhere in the press. The juxtaposition in time with McMastergate and this horrific cult murder should be duly noted. Here are 2 other murders by such men:
So-called "gender-affirming" is pseudoscience gobbledygook and psychobabble. It's equally valid to call it "gender-divisive", "gender-denying", "gender-damaging", "gender-disrupting", "gender-averse", "gender-harmful", etc.,...
Also, gender is NOT "binary". The natural intent of gender is UNITY. One single male sperm cell, and one single, unfertilized female egg cell UNITE, to form a single, fertilized female egg cell, in the female body. That's true of ALL PERSONS. Gender is FEMALE, with a male reproductive aspect. It's the heads and tails of a single coin. NOT the "2 coins" delusion that bogus "gender ideology" promotes. ALL PERSONS are 1/2 female from Mom, and 1/2 male from Dad.... So-called "trans" is as "real" as Santa Claus, but NOT more real.
This is a fantastic summary of McMastergate, if we can call it that. This is the thing people should read BEFORE Jesse Singal's piece, which goes into a greater depth that not everyone will want.
Yes, too many details sometimes make it harder to see the forest for the trees.
But that interview--yikes!
Right? Did you see Julia Mason's comment on that? She was cracking me up.
There have been 2 testosterone products submitted to the FDA for approval and both were denied. A patch and a gel dosed at ~10% of the male dose. Both had been tested in RCTs for female sexual dysfunction in postmenopausal women. The patch showed very modest benefit and the gel wasn't significantly different vs. placebo for the primary endpoint but showed (small) improvements in some secondary endpoints. More acne and hair growth with T but no increase in severe adverse effects. The trials were short (12-24 weeks), were too small to detect rare serious adverse effects, and had high rates of attrition. The FDA's main concern was the lack of long-term safety data. They didn't say women and their doctors should decide - they would not let these products enter the market because there was potential for severe harm.
But here we are with the father of EBM saying we should let children(!) engage in shared decision making about taking testosterone dosed to achieve serum concentrations >6 x the normal female range, and typically lifelong.
Trans exceptionalism strikes again!
"They atoned, and they tithed. They stopped acting like scientists, and instead acted like sinners." Yup pretty much sums up most of the "scientist" currently in this mess!
Thank you for this clear, well-presented explanation not only of what happened here, but also of the all-important larger context. Your closing paragraph is pitch perfect.
Does the father of evidence based medicine not realize that you cannot call something "medically necessary" if there is only low quality evidence that it does what it claims to do, along with mounting stronger quality evidence that it causes harm, not to mention regret?
Also, there are many SR's out there now, the HHS report synthesized a bunch of them!
They only talked about low certainty of benefits in their letter.
Medical decision making involves benefits, risks, alternatives and doing nothing.
If the evidence has low certainty of benefit and high certainty of harm, for instance, then one makes a *strong* recommendation to not do the intervention.
And:
"When low quality evidence suggests equivalence of two alternatives, but high-quality evidence of less harm for one of the competing alternatives" the recommendation is "Strong recommendation for less harmful/less expensive"
https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-023-01895-8/tables/1
The transcript of Jesse Singal's interview of Guyatt is remarkable. Take Lisa's advice and read it . . . Guyatt's inconsistent statements and claims to be too busy whenever Jesse mirrored back his more ridiculous ones and his veiled threats to end the interview . . . just so obviously a guy unwilling to face up to his own hypocrisy and cowardice or the reality that he's dependent on an institution that does not respect and will NOT protect intellectual freedom or the integrity of science. Perhaps what he was subjected to at that hands of colleagues and administrators at McMasters shocked him, and he's in denial. These things became very clear to me: He's not invulnerable; he does have a price (just like any garden-variety sophist . . . or intellectual whore); and he doesn't seem to have encountered (yet) anyone who can get him to admit it.
And, yes! Great closing line, Lisa!
He's clearly been subjected to several struggle sessions. In his defense, he seems much more concerned about the careers of his junior colleagues and students, which is appropriate and commendable.
It sure doesn't make the sciences look good. Sad that they're no more sensible than your average seminar on post-structuralist philosophy or women's studies--but with major real-world costs for trans-identified kids and young people as well as their families.
How is patient autonomy possible if patients remain uninformed (or even disinformed) about the risks and outcomes?
This episode may be another illustration of why "science" isn't going to get us out this mess. As you note, Lisa, there is a much larger context around what happens in the medical facilities. It's that context (the ideology, the affirmation by authorities, the social approbation) that feeds people into medicalization.
I hope he reads your piece, Lisa. You make great points. It seems to me that he (like most) really can't handle the idea that his friends and family just don't want him to appear to be on this side of the issue. And the younger researchers are rightly freaked out given how they've been treated by activists. I disagree that he had some "added responsibility" with how the SRs are used. You can't control what others do with it.
Re Guyatt's motives, it seems to me that a big one is that he doesn't like non-physicians (eg state legislatures) exerting authority on a medical issue over physicians. That usurpation (as he sees it) of physician authority greatly annoys him, and the transqueers got him to believe that his SRs were contributing to it.
Torching SEGM indeed. I also see McMaster throwing them under a bus.
In light of the scandals emerging in the coverage of the mass school shooting in Minneapolis, in which a male formerly Robert, recently right before coming of age, Robin went off his rocker and killed Catholic school children at prayer in the church adjacent to the school. Then he killed himself, after making sure his manifesto was already out there on his youtube channel. The over-representation of violent males in the ranks of patients who call themselves "trans women" will eventually be covered somewhere in the press. The juxtaposition in time with McMastergate and this horrific cult murder should be duly noted. Here are 2 other murders by such men:
https://www.youtube.com/watch?v=yHRqk8IPJPI&t=669s
So-called "gender-affirming" is pseudoscience gobbledygook and psychobabble. It's equally valid to call it "gender-divisive", "gender-denying", "gender-damaging", "gender-disrupting", "gender-averse", "gender-harmful", etc.,...
Also, gender is NOT "binary". The natural intent of gender is UNITY. One single male sperm cell, and one single, unfertilized female egg cell UNITE, to form a single, fertilized female egg cell, in the female body. That's true of ALL PERSONS. Gender is FEMALE, with a male reproductive aspect. It's the heads and tails of a single coin. NOT the "2 coins" delusion that bogus "gender ideology" promotes. ALL PERSONS are 1/2 female from Mom, and 1/2 male from Dad.... So-called "trans" is as "real" as Santa Claus, but NOT more real.
RSVP? Hey, prove me wrong. I dare ya....