Day 4 is just starting now, it is expected that Dr W's counsel Ian Stern (IS) will continue his cross-examination of Professor Gary Butler (PGB).
The public session is starting, Dr W's counsel IS is asking Prof Butler (PGB) to look at documents regarding Pt A.
IS asks PGB to look at a letter from July 2015 regarding Pt A's assessment. IS asks PGB if he has training in dealing with Gender Dysphoria. PGB says he does.
IS asks is there a formal qualification for dealing with patients with GD? PGB says "as yet there is no actual qualification but we are in the process of developing an appropriate qualification."
PGB admits there is no qualification and there are no formal qualifications for treating patients with GD.
IS asks PGB to look at the consent forms that PGB used with Pt A. The forms are signed by the mother, PGB and by Pt A. PGB confirms that his recommendation was to prescribe blockers.
IS asks PGB did he direct the GP to prescribe and administer the medication, PGB confirms. Pursuant to that there was a shared care guideline plan, PGB says that was standard.
IS continues to discuss Pt A's docs regarding the blocker PGB recommended for Pt A. IS questions the frequency of hospital follow up appointments, he asks was there a key worker present in July, PGB says there would have been as they "always do".
IS asks PGB if what the shared care plan proposes is that the individual will be on blockers for 12months then will begin on CSH if needed. PGB says this is principally used for 16 +
Re blockers GP responsibilities the guidelines state there are no important interactions with any other drugs, PGB says that was "true at the time".
Guidelines suggested loss of bone density as indicated on the product info leaflet means that blockers should not be continued for longer than 6 months.
PGB says that bone density studies since, have shown that bone density doesn't decrease, they remain static and that stopping the blockers allows the recovery of the bone density.
There are many factors to consider including psychological wellbeing when prescribing PB says PGB. Trans healthcare is completely unique he says.
IS posits that the dose that Dr Webberley prescribed to Pt A was correct, PGB states that it is not just about the bone density. IS says this is PGB's "opinion". PGB says "It's not my opinion, it's fact".
PGB says that it's not recommended to use testosterone sachets as you can't adjust the doses. PGB maintains the dose was still too high for Pt A and was inappropriate as it cannot be adjusted. IS Apologises that he is about to present a doc that PGB doesn't have.
IS presents an email from 2016 to another Dr about Pt A, stating that Pt A had been prescribed 1/4 of a sachet by Dr W which he said was "far too much" but in a previous letter to the same GP he had stated that it was 1/2 a sachet dose. PGB cannot account for the discrepancy.
IS presents docs regarding tests done on Pt A re bone mineral density - Bone age of Pt A on 30/07/2015 is 11 years, normal bone age. Bone age on 15/09/2016 is 13 years, normal bone age.
Prof Butler's letter, however, states that the bone age is 14.1. IS asks PGB to account for this.
"The radiologist has written 'normal'" says IS. PGB says what he did was a different form of assessment and is more detailed. IS asks is it in the records? PGB says it will be in the clinical report.
IS doesn't have the clinical report, he has the radiological assessment which has Pt A's bone density as "normal". IS asks where he will find information about the bone age of 14.1. PGB says it is "likely to be in the patient's notes".
PGB says that it is "an excessive advance for a person agreed 11 or 12". IS asks does normal growth resume when PB stop? PGB says Pt A's rate of growth was exceeding normal acceleration of growth and that this was a consequence of an excessive dose of CSH.
PGB says it was excessive growth due to the CHS prescribed by Dr W and that it would reduce the adult height of Pt A, says he assessed this by looking at the rate that females are supposed to grow.
IS asks if PGB saw Pt A after 2016? PGB says no. PGB does not know the height of the patient now but thinks that they will be much smaller than they could have been.
IS discusses Pt A's shoulder width, in 7 months, the patient's shoulder width has increased by 11mm, asks PGB if that is correct, PGB says if it's in the notes it must be. In the following 6 mth assessment, the shoulder width has increased by 1mm.
Following this 2nd assessment, PGB said in his letter about Dr W's treatment of Pt A there was a "significant growth in the shoulders" says IS, asking about the 1mm increase. PGB says that he was comparing it with the hips.
IS tells PGB that in 2017 Pt A and his twin sister were the same height. IS asks PGB if height prediction is an inaccurate science? IS asks PGB if predicted height is largely based on hereditary factors, PGB says that is correct.
IS says in PGB's letter that he described Pt A's deepening of the voice as a "slight deepening". PGB states this is a subjective assessment. IS states that Pt A is now 172cm and his twin sister is 171cm. PGB states that that information is irrelevant.
PGB states that the key factor is actually whether a 12 year old should be prescribed CSH. PGB asks questions to IS, Chair says it's inappropriate for a witness to ask questions of the counsel.
IS says "under your care as we can see in Sept 2015, what was your plan for this patient, obviously if he couldn't have testosterone then he would have been on blockers for about 5 years?"
PGB says "that is the case with very young transgender patients who start PB's early on, that is the reason in the past why PB only started at 15-16."
Following the Dutch study that showed that blockers could be started safely at a younger age. There has always been international debate around starting CSH earlier, maybe 15, but not as young as 12.
IS asks wasn't it the case that the Mother of Pt A was also pressing for Testosterone- that isn't the treatment plan offered states PGB.
PGB stated that some people do elect to stay in that "transgender identity" for the rest of their lives but some don't. He adds that CSH would prevent young people from challenging their gender should they so wish.
IS says PGB has spoken about the physical effects of PB and that they are not harmful, PGB says their own research and the Dutch study shows that there is no deterioration of bone density.
PGB says when blockers are used in males with prostate cancer it is a different situation with an older male than a younger one.
IS asks about the mental effects of being in “gender limbo” for the period of time they are on PB. PGB says that there is documentation around that.
IS asks if PGB’s letter says that Pt A’s long term intention states "full time change", PGB confirms.
IS asks about previous medical history of Pt A, and PBG’s notes,“slim female type but presenting as a male”, "Pubic hair stage 1," "no intersex condition present".
PGB says they would have talked about fertility in detail, even with an 11-year-old. IS having trouble reading PGB's notes, PGB says he thinks it says "fertility".
IS asks PGB to look at his own doc from 10th Sept 2015, PGB says they had taken the history of Pt A on a previous occasion. “Fully consented, discussed fertility,” say PGB’s notes.
Pt A had progressed to Tanner Stage 2 by this meeting, according to PGB’s notes.
Following the meeting, treatment status from PGB’s notes say Pt A had started one brand of blocker and moved on to another brand of blocker, says PGB. PGB’s notes say Pt A “had had one” of the monthly injections.
IS reads from PGB’s notes on Pt A: Initially depressed, calm now, since on the 3monthly blocker. Twin sister growing taller, developing in puberty fast.
Blocking of puberty had caused the development of breasts to regress, says PGB.
IS reads following meetings notes from PGB on Pt A: Was on T gel, felt happier/better.
IS: You are aware Pt A’s mother made a complaint about you, both to the GMC and to the hospital? PGB: "That’s right."
IS asking PGB if there is anything he wants to say about Pt A’s mother’s complaint letter about him. PGB says that they had raised complaints about another Dr and hadn’t informed them of the complaint about him.
PGB asks IS does he not want to talk about the notes to do with Pt A’s voice breaking? IS says he’s happy to discuss. PGB talks about the enlargement of the clitoris and “the clear testosterone effect on the body of a 12-year-old child”
IS: Pt A’s mother maintains that there were “threats” of stopping the PB’s if she maintained receiving care from Dr W. PGB says NHS service specifications mean they are not permitted to do that.
Pt A’s mother claims Dr Butler told her the UK was years behind the prescribing of CSH to younger children.
Pt A says that Prof Butler implied that Pt A could start earlier than 16 but when she next met him PBG “casually shrugged off” the suggestion and said that it would only be available for 15 year olds.
Pt A's mother says she begged PGB to give Pt A CSH as it would be life-saving for him. PGB says it’s not possible under the NHS for under 16’s to receive CSH, so therefore he couldn’t offer it to Pt A.
IS asks PGB if he contacted Pt A’s Doctor and asks did he tell the Dr to no longer administer them if Pt A was still taking CSH.
IS states the Pt A’s mum says she tried to call PGB and never got a call back, and that she was no longer able to communicate with PGB.
The reply to Patient A's Mum from UCLH stated that young people may be given hormones from 14 in exceptional circumstances, says IS. PGB states he doesn't know of any exceptional circumstances where someone under 16 could be prescribed CSH.
SJ says PGB was asked about the TW2. SJ wants to see this document. PGB explains how the TW2 is used - it's a relatively straightforward calculation he says.
The hearing is breaking until 12.
PGB: I have one further point about Pt A, when we're looking at growth measurements, a sudden growth rate in response to that treatment is abnormal and isn't something we would normally see.
IS says you've made that clear in your view...PGB interrupts and says "It's not my view, it's my professional opinion", says he is an expert. IS reminds PGB that he is not attending as an expert but as a witness.
IS says that PGB stated he was concerned about Dr W's processes, IS asks did he contact Dr W to ask her about these concerns? PGB says he didn't have contact info for Dr W
PGB says he contacted GIDS rather than Dr W. PGB says that previous attempts to contact Dr W were unsuccessful. PGB says with other patients he was unable to contact her "to the standard" (?). PGB says he took advice from the Trust.
IS presses point, asks had he tried to contact Dr W prior, PGB says "with other Patients...I cannot remember...whatever is written is written..."
IS asks did he try and contact Dr W about Pt A, the Pt in his care? PGB says they stopped Pt A's Testosterone as a result of his (PGB) guidance and so he had no further contact with the Patient.
PGB says they sent offers to attend the clinic to Pt A but they weren't taken up and he had no further contact with him after that.
IS clarifies if the records the GMC hearing have, are all the records available relating to Pt A? PGB confirms.
IS: Reads from PGB statement about the letter he received from Dr Patel, PGB confirms that prior to receiving that letter he had had no involvement with Pt A. IS asks if PGB knows Dr John Dean. PGB says he does.
PGB says Dr Dean is the Clinical Director of the West of England GIC. IS asks how well he knows Dr Dean, PGB says just in a professional capacity.
IS is asking if anyone from his defence team has any further points or questions. Chair asks if SJ has the TW2 doc, SJ says not yet, adds that when he gets it IS should have an opportunity to ask any questions that emerge from it.
SJ: When you were dealing with the structures of Tavi and UCLH you talked about a combined service. You said "We always treat a patient with a member of the GIDS team present" Could you explain why you do that and what is the significance?
PGB says it's important to have a multi disciplinary team because they all have different areas of expertise. says he is an endocrinologist and doesn't have expertise with the mental health and wellbeing of young people.
PGB says a lot of young people that see us have co-morbidity and other mental health issues too.
SJ wants to clarify the training required to prescribe blockers.
SJ asks if the prescribing is done by consultants within UCLH, or may be done on a shared care arrangement and the GP does the prescribing on the recommendation of the UCLH team.
SJ asks about Tavi DSM4, asks PGB to clarify why a diagnosis is important. PGB: "It's fundamental, there may be other factors going on in a young person's life. It may be associated with other mental health issues, school issues, or even child abuse".
PGB: It's important to follow that very closely, it's a very different mode of practice from my typical practice. We need to work in parallel with the team.
SJ: The assessment you get from Tavi re the dysphoria - do you know how that assessment has been conducted and over what time? PGB: yes I do, it's all documented in the reports.
PGB: "The assessments are usually a joint report written by a pair of clinicians".
SJ: How is the process of consent taken and under what time? PGB: There is a pre-discussion that takes place before we receive the referral, by the time patients get to us there has been a joint decision about if they can go forward.
PGB says there are now forms to be filled in including the consent of the patient and their family.
They must first meet to discuss the medication that will be given to them, then they have to wait 2-3 months until they can see them again to think about it. After that they take written consent.
SJ asks about fertility loss, PGB says that it is an important factor as CSH treatments can affect fertility long term so that is something that is thoroughly discussed.
Research shows blockers are reversible, but with CSH use fertility can not be recovered after use. We counsel Pt's about fertility preservation. Many do choose fertility preservation.
PGB says that Pts must also understand what would happen later with stopping treatment if they changed their mind and that may not be successful.
PGB says when the child approaches 16 they will have additional counselling before starting CSH, specifically about fertility, adds that fertility is "discussed on a regular basis"
PGB confirms he contributed to but was not named in the NHS 2017 guidelines. SJ asks what source guidance clinicians look to nationally and internationally?
PGB says BAGIS is a recently formed group representing clinicians who work with GD people, he says their aim is to set professional guidelines for the treatment of transgender patients - the standard of care is currently being written.
PGB says at present only people that meet certain criteria can join. That criteria is being a recognised specialist in that area, have practised of a certain level volume of patients each year. PBG says that could include GPs. Training events are open to non-members as well.
SJ asks PGB to look at the records of Pt A, the consent form. "this is the Tavi form, but it also has the UCLH form, has this been created jointly?" PGB says yes though adds it is an old form.
SJ: At what stage of the 2 stage process would this form typically be signed? PGB this form is the consent form for prior to starting treatment, after a minimum of 2 visits with all the clinical assessments done. Pt A's was done on their 2nd visit.
SJ: as I understand it there are known and unknowns in starting treatment, are they both covered in this consent form? PGB says yes.
SJ asks PGB about the shared care doc. SJ asks how this issue is addressed with Patients or carers? PGB says it's usually sent to the GP after the 1st visit, to find out if the GP will provide shared care.
PGB says a similar form is used in children with precocious puberty as it is a similar treatment.
SJ reads from the form, ays that it says "frequency of hospital appointments" and asks if some of these happen before treatment starts. PGB says that's correct. Tavi GIDS do not do clinical assessments or provide treatment direction PGB says.
PGB says there can be issues around their capacity to consent from young people, co-morbid health issues or social issues that may interfere with their treatment and that those things might need sorting out first.
SJ asks PGB about his statement that hormones can change psychosocial presentation. Asks does this make a difference to their decision-making process? PGB says PGB says that first, they need to consider the emotional development of an adolescent/teenager.
PGB says that psychosocial functioning is a consequence of sex hormones and that having those withdrawn may cause issues of anxiety, depression, etc. PGB says some people aren't able to tolerate CSH and that the emotional side should be considered as well as the physical side
PGB says the emotional side of treatment is fundamental. SJ says that PB are fully reversible and give the Pt the opportunity to think, allows them to be "in a holding position" asks if that's correct?
PGB says it's more than a holding position as they are still developing and exploring their identity.
SJ asks what the impact is on the psychosocial development of initiating CSH at a younger age, asks if PGB has experience on this?
PGB says no one has evidence of information on it as "It's just not done" says gender-affirming treatments aren't given until 16 and that is the case in the main European states as well.
SJ requests a break, says he hopes he will receive the TW2 doc and clinical records. (looking for the letter from PGB that references the sachet dosage info). PGB says there may be additional paper records for Pt A.
SJ says: PGB you said there "was a rapid acceleration in Pt A's growth" but IS pointed out that it was marked 'normal' by the radiology report. As you (PGB) said there was another report that states that it wasn't normal we hope we can get a copy of the second report.
PGB says he will try and find the evidence he has raised of the second report. The Chair asks him if an hour will be enough to find the document? Chair breaks for lunch, back at 2.05.
SJ is re-exaimining PGB, he says that they still haven't been provided with the missing document. Thanks PGB for looking for it. He invites PGB to look at the documents relating to Pt A's records.
SJ asks PGB to look at Pt A's records from 2015. "Is this the image that you were talking about (was the subject of the report?" he asks PGB. PGB says he thinks it is another image enclosed.
The image is an x-ray of skeletal growth, citing a bone age of 11years. SJ asks PGB to elaborate on chronological age and bone age. PGB says bone age is an index of biological maturation by comparison, according to age.
Normally it's usually for 1 year of bone age to be 1 year of calendar age, if you go to the original bone age report the child is slightly less than the actual age of the child.
Moving forward in time a year the bone age has advanced to be 13 years, 7mths advanced. That's not what would be expected so the child would not then achieve their full growth potential.
This is part of the specialist monitoring process we would do, the constant assessment is something done the world over. SJ says he has no further questions.
Chair asks PGB about diagnosis and the diagnosis of GD and you explained that the diagnosis is made by GIDS, not by you, is that right? PGP says yes. Chair asks about PGB's formal training in GD and PGB says he does have it through EPATH and ESPE.
But you have no formal qualification in GD? asks Chair. PGB says he is trained as a pediatric endocrinologist.
Chair: After a diagnosis of GD, patient is referred to UCLH and in due course, treatment may start and there is monitoring after, asks who does that? PGB says it's done by Tavi, GP and UCLH.
Chair asks if a mental health professional coupled with an MDT, was undertaking the care of pt with GD - who would be responsible for the follow-ups?
PGB notes a difference between adults and children says the pediatric endo is recommended for kids.
Chair asks where this recommendation is, PGB is struggling to answer
Chair asks PGB is it a matter of determination of competence to prescribe, as opposed to a rule that means it must be done only by someone with the relevant qualifications and skills?
PGB says "Any form of hormone treatment would not normally be administered by someone without training in that field"
Lay tribunal member asks PGB about the prescribing of CSH to children under 16, asks where is the evidence coming from and what is it that has lead the NHS to say it is not advisable?
PGB says there is not enough evidence. ""The review of the evidence is there is no evidence" suggests panel member, PGB agrees. PGB says "There have been no studies, no one has experience of treating someone that age", says PGB.
Panel member says, "so it's only not advisable because there is no evidence, not that there is evidence to suggest a negative outcome?" PGB agrees.
PGB asked about the diagnosis of GD and the training that is provided in this area. PGB says the ped endo training is ongoing, with additional training for those that work in the area of gender dysphoria.
SJ asks PGB about the training or experience needed to diagnose GD, he asks who typically makes the diagnosis in GIDS?
PGB says the clinicians working at GIDS make the diagnosis and that they have varied backgrounds. He adds that the ped endo also goes through the background from which the diagnosis was made to check themselves that the diagnosis is correct.
SJ asks what qualification is needed to make a diagnosis of GD? PGB says the person would need to be fully qualified as a psychologist/psychiatrist etc and that they would need a period of appropriate training, even then it's typical for clinicians to work in pairs, he says.
PGB says the diagnosis of GD should then be made by an MDT.
SJ asks PGB to explain the NHS Service Spec that gives details of what's required, he says it's a min 4 assessments over 6 months before a diagnosis can be made. "The young person must cooperate with GIDS and ourselves if they wish to receive treatment."
PGB says regular monitoring is a requirement under the NHS spec, continued care is conditional on continued follow-ups.
SJ asks if when prescribing an unlicensed medicine it's the case that you must be satisfied that there is enough evidence or experience that medicine is safe? PGB says yes.
PGB says it's the Drs clinical responsibility to ensure that the treatment is appropriately monitored, particularly when it's life changing medication, "certainly in the field of hormone treatments."
IS is asking was GD on the curriculum? PGB says it's coming. IS asks was it on the curriculum in 2016? PGB bats off the question, says "probably not formally".
PGB has left the hearing, SJ has no more witnesses, he says Dr Walters will be the witness tomorrow.
Chair has adjourned the case until 9.30am tomorrow.

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