British Medical Journal - Article on GIDS Study of Puberty Blockers

[Popchyk]

This article. by Deborah Cohen and Hannah Barnes has been made free to view. Deborah Coren is the journalist who did the Newsnight report into this subject.

Previously you had to subscribe to see it. Good on the BMJ.

www.bmj.com/content/366/bmj.l5647

It mainly repeats the Michael Biggs/Transgender Trend stuff that we know about. But might be interesting for people who are new to this.

A couple of things I didn't know.

"We sought the views of methodologists and clinical trial statisticians, but few were prepared to speak publicly for fear of reprisal".

Doesn't that just say it all?

I knew there was obfuscation around ethics approval for the study. The first ethics committee (REC1) rejected the study because there was no control group, among other things. The study was then presented to a different ethics committee (REC2) with no changes. It was passed, however all members of the committee of REC2 (apart from lay members) worked at institutions with Russell Viner, the principal investigator of the study.

The BMJ article states that the Health Research Authority is now investigating this, among other things.

Seems like there is a concerned parent of one of the subjects who is mentioned as raising concerns at this. Maybe this parent is taking legal action?

The HRA investigation is set to conclude at the end of September. So very soon, hopefully.

Interesting, thank you.

Thanks for sharing

‘For fear of reprisal’. I’m speechless

I am really glad that some of this stuff is coming out from pretty neutral, non-emotive sources. I have a friend and I worry about her going down the puberty blocker path with her daughter. But it's very difficult to reach he without a very specific type of source, she's so black and white in her thinking. Something like this might give her pause.

I'm really hoping that the HRA report back soon.

But the HRA did ask for updates on the study for 3 years, but did not follow up when no responses were received. So they may well be in arse-covering mode themselves. Seems like everyone is compromised so the truth will be hard to get at.

This was their statement after the Newsnight programme.

www.hra.nhs.uk/about-us/news-updates/statement-response-bbc-newsnight/

"Unfortunately, as this study was reviewed in 2010, before the formation of the HRA and when applications were submitted in hard copy, we no longer have a copy of any study documentation which was submitted only in hard copy. This includes the Participant Information Sheet (PIS)".

I think we are going to find that lots of documentation is missing and cannot be located. From both the Ethics Committee side and from the clinical study side.

GIDS said that the data were from a “small sample” and therefore no “meaningful conclusion” could be drawn. It added, “All patients were seen regularly by mental health professionals. They concluded that there was no evidence of harms that could be directly attributed to the treatment and that continuation of the study was appropriate.”

Isn't this a self-contradictory statement?

..."small sample” ... therefore no “meaningful conclusion” could be drawn. ...They concluded that there was no evidence of ...

Yep, I noticed that.

Too small to draw a meaningful conclusion. So why did you design the study that way if the results would be too small to draw meaningful conclusions? What is the actual point of the study if you cannot conclude anything from the small set of data?

And yet. They go on to conclude that there was "no evidence of harms" on this study. From the study that they simultaneously claim is too small to draw a meaningful conclusion.

It's not mentioned in this paper, but apparently the vast majority of trans-identifying teens desist after several years of 'watchful waiting' (citation?). This paper indicated that all children treated with blockers go on to have cross-sex hormones.

Isn't that alarming?

Doesn't that imply that treatment with blockers causes children to continue being dysphoric?

"We sought the views of methodologists and clinical trial statisticians, but few were prepared to speak publicly for fear of reprisal".

It was passed, however all members of the committee of REC2 (apart from lay members) worked at institutions with Russell Viner, the principal investigator of the study.

Wow. Just wow. On both counts. Well done the BMJ for carrying this (and making it open source).

Just chipping in on the HRA arse covering angle - I'm not sure what they are saying will wash. I was working on a study with approval under the old system when the HRA was established. We had to transfer our study across to the new HRA system (a paperwork exercise, but it required full submission of all documentation). We were also obligated to provide annual updates to HRA, university ethics and also to some Trusts (under their governance arrangements). End of study also triggered an end of study report to the above. I find it somewhat unlikely that there was no paper trail.

Yeah, that worries me umbel.

The HRA is already saying that they don't have some of the documentation, so all it needs is for GIDS to say that guess what, they don't have some of the documentation either.

HRA should be investigating what happened to those hard copies, not waving it away with "well, it was before we were set up".

It is not normal to destroy documentation on an on-going study, surely? And the Patient Information Sheet is a key document.

And if some of the documentation has been destroyed for this study, then are other studies affected?

Questions to be asked about the HRA. Hard copies on an ongoing study went missing and they didn't realise for 9 years? They were asking GIDS for updates, they must have realised that their own hard copies had gone missing. Did they ever ask GIDS for the missing information?

Needs a proper investigation by a completely independent team.

Just to update this.

I emailed the HRA asking when they will publish their report.

Got this back.

An investigation into concerns raised around the study An evaluation of early pubertal suppression in a carefully selected group of adolescents with Gender Identity Disorder (reference 10/H0713/79) is underway. We expect this to be complete, as planned, by the end of September and will publish it on our website once we have followed up as necessary with the other parties involved. Please note that the nature of this follow-up is dependent upon the outcomes of the investigation, and so publication is unlikely to be by the end of the month.

So they reckon they'll finish the investigation by Monday next week. Which is good.

But, given the follow-up that will no doubt be required, they can't say when they will publish the report.

At least they had the decency to reply, I suppose. And at least the investigation will finish on time.

But no doubt GIDS will stall for time on their end, which could result in more delays.

We sought the views of methodologists and clinical trial statisticians, but few were prepared to speak publicly for fear of reprisal

I am just trying to think of another topic where this would be the case. Of course vaccines and climate change are similarly controversial but do methodologists and statisticians in these fields feel under threat?

How did we get to this point?

BMJ just landed on my doorstep this morning- this is the cover story! Normally picked up by news outlets so fingers crossed

Front page

I think there is a growing body of medics who are concerned about this. Quietly sceptical, and chatting amongst themselves about issues with people in their clinics.

Because they are good people, good clinicians and keen on not harming their patients.

BMJ can't be held hostage by mermaids et al - unqualified groups with opinions just can't hold sway over evidence base.

Roll on the Cochrane review of all this shit, that's what I say. Put an end to it once and for all, sadly too late for the TiFs with cardiovascular and bone health issues because of the T they were put on to give them beards and, oops, the menopause

I'm a clinical trial statistician and have worked on methodology. My guess would be they sought opinions from statisticians based at universities rather than those working in industry (pharma/biotech). Having worked in both settings there is a noticeable atmosphere in universities of having to comply with the sjw/woke agenda on all issues including trans.

Brilliant. Was peaking my Gp friend Recently around this. Hopefully he'll see this.

Glad the word is getting out.

There have been two responses on the BMJ website.

www.bmj.com/content/366/bmj.l5647/rapid-responses

One from four doctors at the Royal Children's Hospital in Victoria, Australia. This is a fully-evidenced response stating that current evidence suggests that puberty blockers commonly results in loss of bone mineral density.

The other one is from a Senior Research Fellow in Bioethics at the University of Melbourne.

This person offers no opinion on the article itself, but asserts that journalists should not be allowed to write for the BMJ.

Deborah Cohen, the author of the article, was investigative editor of the BMJ for 13 years.

Not in the BMJ, but a Swedish psychiatrist, specialist in child and adolescent psychiatry, has published an article, stating that there needs to be an independent investigation into the probably biggest health scandal in Sweden's history.

www.ihmistenkirjo.net/blog/psychiatrist-gender-dysphoria-spreads-like-an-epidemic-online

He initially posted it on Medium, but it was removed after pressure from the trans lobby. Medium also suspended his account.

This makes me think I should do a FOI request for this NIH (US) study. This principal investigator is ms. “Trans Infants Unbuttoned their onesies” IIRC (Johanna Olsen)

grantome.com/grant/NIH/R01-HD082554-01A1

Presumably you are in the US, FWRLurker.

Not sure of how to find out info there. I am in the UK.

But yes, be good to get as much information as possible into the public domain. Every tiny piece of information is valuable.

You have a better system in the UK however it is possible to ask for info - we have a freedom of information act which applies to any publicly funded research.

FOIA requests are Interestingly how climate deniers got some of those embarrassing emails - deniers are constantly FOIAing every climate study and then trumpeting the 1% where a scientist did something stupid, usually Conflict of interest stuff.

FWRLurker, I think the endocrinologist Michael Laidlaw did some pertinent FOIA requests already. I will dig around for a link.

And so it starts, imagine this creep digging through your twitter follows. Shudder.

LEAVE KIDS ALONE.