BMJ Prof Carl Heneghan, Evidence Based Medicine Oxford (Panorama, Trans Kids:) 'Gender-affirming hormone in children and adolescents – Evidence review' concludes 'There are significant problems'

[R0wantrees]

Professor Carl Heneghan was interviewed on last night's Panorama & as a consequence of his analysis concluded that 'informed consent is not possible'

BMJ EBM Spotlight paper:
'Gender-affirming hormone in children and adolescents – Evidence review'
Posted on 25th February 2019

(extract)
"Gender dysphoria occurs when a person experiences discomfort or distress because of a mismatch between their biological sex and gender identity. Gender dysphoria can arise in childhood and adolescent which raises many questions about how best to handle the condition. This post sets out the current evidence for gender-affirming hormones in adolescents and children to aid decision making. (continues)

"Conclusions

There are significant problems with how the evidence for Gender-affirming cross-sex hormone has been collected and analysed that prevents definitive conclusions to be drawn. Similar to puberty blockers, the evidence is limited by small sample sizes; retrospective methods, loss of considerable numbers of patients in follow-up. The majority of studies also lack a control group (only two studies used controls). Interventions have heterogeneous treatment regimes complicating comparisons between studies. Also adherence to the interventions are either not reported or at best inconsistent. Subjective outcomes, which are highly prevalent in the studies, are also prone to bias due to lack of blinding, and many effects can be explained by regression to the mean.

The development of these interventions should, therefore, occur in the context of research. Treatments for under 18 gender dysphoric children and adolescents remain largely experimental. There are a large number of unanswered questions that include the age at start, reversibility; adverse events, long term effects on mental health, quality of life, bone mineral density, osteoporosis in later life and cognition. We wonder whether off label use is appropriate and justified for drugs such as spironolactone which can cause substantial harms, including death. We are also ignorant of the long-term safety profiles of the different GAH regimens. The current evidence base does not support informed decision making and safe practice."
blogs.bmj.com/bmjebmspotlight/2019/02/25/gender-affirming-hormone-in-children-and-adolescents-evidence-review/

BBC 'Trans Kids: Why Medicine Matters'
More young people than ever are exploring their gender identity. Last year, two and a half thousand under-eighteens were referred to NHS England's gender identity clinics for support. Some are hoping to get access to potentially irreversible treatments as soon as they can. Doctors are divided about the best way to help.

Dr Faye Kirkland investigates how much we understand about the care being offered to transgender children."
www.bbc.co.uk/programmes/m0002tw1

thread
www.mumsnet.com/Talk/womens_rights/3517453-Panorama-25-Feb-20-30hrs-Trans-Kids-Why-Medicine-Matters-Thread-title-edited-by-MNHQ

Good for Prof Heneghan. The off-label use of medications with these suspected long-term outcomes, on the basis of this quality of evidence, on children who may not be able to consent for a whole plethora of reasons, is just mind-boggling.

And if there is anyone out there considering any kind of legal action on the basis that they or their child was subjected to irreversible harms as a result of treatment they did not legitimately consent to, I for one would be happy to contribute to a crowdfunder.

BMJ Published 29 October 2018
'Redesigning gender identity services: an opportunity to generate evidence'
authors: Richard Byng, general practitioner and professor in primary care research, Susan Bewley, emeritus professor of obstetrics and women’s health, Damian Clifford, consultant liaison psychiatrist, Margaret McCartney, general practitioner and freelance writer
(extracts)
"A recent feature in The BMJ implied that new services are all that’s needed to improve transgender healthcare. Providing timely, sensitive services for all, including those who decide to not pursue treatment or detransition, is important. But the article did not question the steep rise in referrals of mainly young women or the potential harms of medical overdiagnosis and overtreatment" (continues)

"Regulated medical practitioners should follow a framework of evidence, not simply respond to client expectations. Creating that evidence to inform quality standards is an ethical imperative. We need research to explore the interplays between gender identity, mental health and neurodevelopmental problems, sexual orientation, autogynephilia, and unpalatable gender roles" (continues)

www.mumsnet.com/Talk/womens_rights/3410257-BMJ-article-We-need-research-to-explore-the-interplays-between-gender-identity-mental-health-and-neurodevelopmental-problems-sexual-orientation-autogynephilia-and-unpalatable-gender-roles

Excellent piece. I was asking questions on another thread about research last night and this answers some of my suspicions.

Glad there is a thread on Carl - or Dr Carl, as I want to call him.

Even more glad he's published that paper. This sounds strongly worded:

"The current evidence base does not support informed decision making and safe practice."

Reading the bmj piece properly - this is bad
bad science. No controls (you don't compare to people who don't get the treatment, or a different treatmet)! No blinding (they didn't disguise who got the treatment, so bumper placebo effects), mean reversion (in the long run most things end up average - so would resolve without intervention)!

Ben Goldacre used to have lively bad science sceptic forum. I think he is fairly woke on trans matters though. Wonder if this paper might be way to make headway with "sceptic but must be kind to trans people" crew?

It's so bad it makes me think people like Ben G have just decided its lack of precedent proves the normal rules don't apply.

Something like Hitler's 'big lie': tell a lie big enough and no one can believe you'd have the front unless you were telling the truth

It would never come into their heads to fabricate colossal untruths, and they would not believe that others could have the impudence to distort the truth so infamously

Keep sending this stuff to the lottery. They noted the difference in outcomes between those who were referred to GIDES and those who had dealings with Mermaids (the high trsnsition rate). They should be aware that experts say that due to the dangers and lack of research, there can be no informed consent for the path advocated by Mermaids.

there's a lot of information about The Tavistock on recent threads:

www.mumsnet.com/Talk/womens_rights/3509817-Times-16-2-1-9-Staff-at-trans-clinic-fear-damage-to-children

www.mumsnet.com/Talk/womens_rights/3510367-Tavistock-article-in-the-DM

Good that the sort of peer review that should have been done at the time that the studies were originally published is now being done.

On spironolactone - it's an androgen blocker that was originally formulated to treat hypertension and other cardiovascular problems. I take a low dose a couple of times a month to treat acne: for me, it's a wonder drug (I can virtually see my spots receding) though it comes with side-effects. Primarily breast pain (in men, it causes breast tissue to grow - which is obviously a desirable side effect for transwomen) and it's also a diuretic (which can cause weight loss but also kidney problems)

Although it works brilliantly for my skin, I choose to take a lower dose than the doctor originally prescribed (both in terms of frequency and amount) because the side-effects can be very dangerous. It's recommended to avoid eating foods like avocado, bananas, spinach and sweet potato (aka otherwise healthy foods) because these are high in potassium and can lead to hyperkalemia - which can be fatal.

The thought of young people being given this and expecting them to stay on it for the rest of their life is horrific TBH. And yet it gets minimised as "titty skittles", magic sweets to make you grow breasts and "become a woman" with no problems at all

News report here:

www.bbc.co.uk/news/health-47456938

Young transgender people are being let down by the "terrible" quality of evidence underpinning their treatment and care, a leading researcher warns.

Prof Carl Heneghan, from Oxford University, said there was an "urgent" need for a new regulator in the field.

He said much more "rigorous" and "robust" research was needed into the effects of drugs given to young transgender people.

But the Department of Health says it has no plans to create a new regulator.

Prof Heneghan, director of the Centre of Evidence Based Medicine at Oxford University, along with Prof Tom Jefferson, who is also a clinical epidemiologist carried out an independent analysis of the most recent international research on medical interventions for the BBC's Panorama programme.

Prof Heneghan said "One of the key issues is to be able to say to parents and children in making a decision... 'Here's an informed decision based on the evidence.'

"The quality of evidence in this area is terrible."

Times article today should be taken very seriously by health care providers, politicians & parents/carers concerned for the well being of children & young people questioning their 'gender identity'

'Doubts over evidence for using drugs on the young'
by Professor Carl Heneghan
(extract)

"Children are not small adults; their changing body composition requires careful dosing; their physiology creates unique challenges that increase risks, and off-label use may lead to serious and life-threatening consequences. In my view, given the paucity of evidence, the off-label use of drugs that occurs in gender dysphoria largely means an unregulated live experiment on children.

Treatments for gender dysphoria in children and adolescents include suppressing puberty and the use of gender-affirming hormones before decisions about gender-affirming surgery. The collection and evaluation of evidence, particularly when it comes to ensuring their safety, should therefore be a priority. It is not." (continues)

The Department of Health told the BBC’s Panorama programme that it was “committed to ensuring thorough accountability and oversight. . . and will review any arrangements when appropriate”. Its response is pitiful — “review any arrangements when appropriate”, what does that mean?

The BBC investigation I participated in highlights the considerable uncertainties that require addressing to inform safe care for gender dysphoria. If in doubt, ask for the evidence. " (continues)

www.thetimes.co.uk/article/doubts-over-evidence-for-using-drugs-on-the-young-2vk26hrvx?shareToken

thread discussing the four articles in today's Times focussed on medical professionals whistle-blowing of Duty of Care & Safeguarding children concerns:

www.mumsnet.com/Talk/womens_rights/3553935-Times-article-calls-to-end-transgender-experiment-on-children

Gawd these drugs been given to children. Awful