Lupron Guinea Pigs: Two Decades of Experimentation on Autistic Children (Parts One, Two and Three).

We take an in-depth look at Lupron, touted in the noughties as a quack 'cure' for autism, embraced later by doctors as 'gender affirming care'... but still somehow used primarily on autistic children.

Part One

In the mid-1990s, Dutch clinicians used the case of a sixteen-year-old girl, who was experimentally given Gonadotropin-Releasing Hormone agonist (GnRHa) triptorelin at the age of thirteen by her endocrinologist, to create a new protocol for administering hormonal treatments to children experiencing gender dysphoria before the normal age of consent. The ‘Dutch Protocol’ as it came to be known, was introduced to the British public consciousness shortly after when three million people in the UK, watched Channel 4’s 1996 documentary The Decision: The Wrong Body, in which British gender dysphoric young people went to Holland to meet peers who had received hormonal gender treatments as children. Stephen Whittle (a woman who claims a trans identity) who had set up Press for Change in 1992, to campaign on transgender issues in the media, began to push for young people in the UK to have access to these puberty blockers. Whittle had a long way to go, however; the UK’s biggest gender clinic, the Tavistock, would not begin to experiment with giving such treatments to children until 2011.

Meanwhile in the US, TAP Pharmaceuticals – a short-lived joint marketing venture between Japanese Pharmaceutical Company, Takeda, and Illinois-based Abbott Laboratories – was marketing its own GnRHa: Leuprolide.  Patented in 1973, approved for medical use in the US in 1985 and better known by its brand name, Lupron, leuprolide was approved for use in cases of prostate cancer but by the mid-noughties it was also being used, off-label and unapproved by the US Food and Drugs Administration, as a ‘cure’ for autism. In 2004, father and son team, Mark and David Geier, filed a patent for their ‘Lupron Protocol’, which involved administering Lupron to autistic children along with chelation drugs (which strip heavy metals from the blood, the use of which has been fatal in at least one case, that of five-year-old Abubakar Nadama), asserting that the autism was caused by mercury poisoning, in turn caused by thimerosal in childhood vaccines. Despite being widely discredited, the Geiers (who also had a history of testifying for litigants in vaccine-injury cases) and their theories gained a following and they would soon have licences to practice in California, Florida, Hawaii, Illinois, Indiana, Kentucky, Missouri, New Jersey, Virginia and Washington as well as in their native Maryland.

In 2005, the Geiers were invited to speak about their ‘protocol’ at the anti-vaccine Autism One conference in Chicago, Illinois. A few years later, in 2008, the Geiers met obstetrician and “natural birth” advocate, Dr. Mayer Eisenstein, in the same city at the Health Freedom Expo and worked with him to set up his Homefirst Autism Recovery Clinic in Rolling Meadows in suburban Chicago. Over the next half decade, the Geiers, along with Dr. Eisenstein their other acolytes/business-partners, administered Lupron injections to autistic children across the US. In 2009, Geier Senior claimed he had treated up to 600 children and a handful of adults with the drug himself.

Lupron did not cure anyone of autism but it did make purveyors of the Geiers’ protocol and TAP Pharmaceuticals a lot of money – Dr. Eisenstein reputedly charged $5 - 6,000 per month for the injections, which, in order to prevent puberty, had to be administered indefinitely, making patients-for-life. Lupron’s marketing team seemed to believe the Geiers’ protocol showed sales potential and in September 2005, mere weeks after chelation therapy caused Abubakar Nadama’s death, TAP Pharmaceuticals, Abbott Endocrine and Missouri-based Lake Products LLC (makers of key ingredient of the Lupron injection, Sodium Chloride) supported the Geiers’ Lupron Protocol patent, Methods of Treating Disorders Having a Component of Mercury Toxicity. The protocol claimed mercury caused autism and that Lupron and chelation could remove mercury from children’s brains. TAP’s marketing team was well acquainted with aggressive marketing strategies; in 2001, its Lupron-marketing techniques got the company embroiled in one of the biggest pharmaceutical lawsuits of all time and it was sued by US government programmes Medicare and Medicaid for $875 million for overcharging them for the drug; incredibly, just four years later, TAP was considering marketing Lupron as a ‘cure’ for autism based on the Geiers’ junk science. Despite the initial support, however, TAP and co. dropped out and by 2008, Abbott Labs and Takeda had disbanded TAP Pharmaceuticals altogether.

While this was going on, across the pond in the UK, two organisations – the Gender Identity Research and Education Society (GIRES) and Mermaids – had been founded and begun to campaign for hormone treatments to be available on the NHS to children identifying as transgender. In 2005, GIRES organized a symposium in London to develop “guidelines for endocrinological intervention” with Mermaids and other medical charities providing additional funding. The symposium was attended by the creators of the Dutch protocol, as well as Domenico Di Ceglie, Director of the Gender Identity Development Service (GIDS) and Great Ormond Street Hospital’s Polly Carmichael and Russell Viner, who would eventually begin hormonal treatment experiments on children at the Tavistock in 2011. Also in attendance was the American paediatric endocrinologist, Dr. Norman Spack.

In the Takeda/Abbott Laboratories 2008 settlement, Abbott Labs hung on to the rights to Lupron, which in 2007 had sales of $600 million and a patent which would not expire until 2015. In California, in the same year TAP Pharmaceuticals was making $600 million in Lupron sales, Sylvia Joanna Vazquez was convicted on horrific child neglect charges. Riffing on the extreme and dehumanising techniques she had learned from Nancy Thomas Parenting classes (and a book given to her by her social worker), she kept three of her four adopted children in cages with buckets for toilets and fed them a restricted diet of bread, water and peanut butter. To the twelve-year-old girl (the one not kept in a cage) she gave shots of Lupron, curtailing her physical development. The case set a precedent, arguably defining medically unnecessary administration of puberty-blocking hormone treatments as felony child abuse.  Nevertheless, that same year, Dr. Spack opened his gender identity clinic at the Boston Children’s Hospital – the first in the US set up to treat children – where he began to administer Lupron as a puberty blocker. He assured parents of trans-identified children that Lupron injections ‘bought them time’ while they considered irreversible ‘gender affirming’ treatments of cross-sex hormones and surgeries.

One of Dr. Spack’s first patients was Jackie, son of Susie Green (and soon to become CEO of the charity Mermaids). Jackie was taken to Dr. Spack’s clinic for puberty blockers from 2007, when he was twelve years old. Around that time, in the UK, Mermaids gave a presentation to parents about transgender medical tourism and Dr. Spack saw several more British children for treatment at his clinic. Dr. Spack was likely to have been the person who advised Green about plans in Thailand to raise the legal age for ‘sex-change’ genital surgery from sixteen to eighteen. She booked Jackie into a Thai hospital for penile inversion surgery for his sixteenth birthday, squeaking in just before the age of consent was raised.

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Part Two

Lupron bears the hallmarks of a ‘solution looking for a problem’. Since its origins as a palliative prostate cancer therapy, it has branched out, being prescribed variously – approved and non-approved by the US Food and Drug Administration – to treat autism, breast cancer, endometriosis, uterine fibroids, infertility, short stature and precocious puberty (approved in 2020). In 2007, Dr. Norman Spack, who treated Susie Green’s son, Jackie, began prescribing Lupron as a treatment for ‘gender dysphoria’, an ailment rarely seen in American children before this time.

The image above shows trends in mentions of ‘transgender children’ in books published between 1990 and 2008. Mentions were non-existent in published books until the mid-90s (when the Dutch Protocol was developed) but shot up by 500% between 2007 and 2008 – the year Dr. Spack opened his clinic. (At the time, there had been no long-term studies on the effects of delaying children’s puberty past the normal age.)

In 2017, Kaiser Health News published an article about the possible negative long-term effects of Lupron-use; the author, Christina Jewett, interviewed young women who had been given Lupron as girls to delay puberty or make them grow taller. They told her that they had experienced the short-term side-effects listed on the paediatric label, which included pain at the injection site, mood swings and headaches. But years after taking Lupron, these young women began to experience health conditions that usually affect far older women. Though still only in their early- to mid-twenties, they had been diagnosed with conditions such as osteopenia (thinning of the bones) and osteoporosis; one had a cracked spine while another needed a total hip replacement; others experienced chronic pain and degenerative disc disease. More than 20,000 adverse event reports were filed with the FDA in the decade between 2007 and 2017.

The most famous historical example of a pharmaceutical company inventing an ailment for its pre-existing product to magically cure, is Listerine. Formulated in the 1880s, the general-purpose antiseptic was used for cleaning feet, scrubbing floors, treating gonorrhoea and other hygiene issues. It was not until the 1920s that Gerard Wheat Lambert, son of the owner of the Lambert Pharmaceuticals, came up with a new word which would make the product fly off the shelves: halitosis. Adapted from the Latin word for breath, halitus, Wheat Lambert Jr. added the scientific-sounding suffix -osis (‘disease’) to make people believe they were the “victims” of a medical condition, which required Listerine to cure it.  Subsequent marketing campaigns targeted women, stressing the terrible consequences of halitosis, which could not be discerned by the sufferer – unmarriageability and isolation – and strongly suggested they should use the product whether or not they believed they have the condition because even "[their] closest friends won't tell [them]".

Lambert Pharmaceuticals developed its Listerine-marketing techniques in St. Louis, Missouri – a relative stone’s-throw away from its peers at Abbott Laboratories in Chicago – which would become a template for future Lupron-marketers at Abbott Labs/TAP Pharmaceuticals to follow: instead of expensively manufacturing a new drug, simply repurpose an existing one and instead of trying to cure an existing illness (which could be difficult), simply invent a new illness and propose your cure – after all, if you never really had the illness, how can you say the drug did not cure it? The beauty of the Listerine scam is its simplicity. The problem with TAP’s investment in Mark and David Geiers’ Lupron Protocol is that autism was an already existing condition with recognisable traits/symptoms. Treating autism with puberty blockers would be profitable because it made patients for life but the fact that it demonstrably did not work meant the drug’s ineffectiveness would likely be exposed, leading to opt-outs at best and lawsuits at worst. Even Dr. Mayer Eisenstein - who joked that before his medical career took off, his ambition was to be "a corrupt, dirty Illinois politician" - was having second thoughts in 2009, when it was proving difficult to get health insurance companies to pay for the drugs. In the US at the time, a climate of paranoia around heavy metals and supposed government cover-ups, anti-vaccine sentiment, charismatic ‘wellness’ and behavioural therapy gurus undermining medical practitioners and the undeniably dishonest behaviour of pharmaceutical companies was creating a readily exploitable market of parents desperate to find a cure for their children’s incurable autism. Would the fact that Lupron did not cure autism be an insurmountable obstacle to Abbott Labs capturing this market? More on this later.

In December 2018, in the UK, Andrew Gilligan wrote an article for The Times about the charity Mermaids, which was being granted half a million pounds of Big Lottery Fund money. He reported opposition to the grant from feminists, who cited, among other concerns, the children’s charity’s promotion of the GP, Dr. Helen Webberley, who privately prescribed puberty blockers and cross-sex hormones to children as young as 12 (one of whom died by suicide aged eighteen, just months after the article was published). Astonishingly, Mermaids continued to recommend Dr. Webberley even after she was convicted later that month of operating her gender clinic illegally. Despite the conviction and subsequent two-month-long tribunal in 2021, Dr. Webberley and her husband, Mike, have continuously operated and promoted Gender GP, their private gender clinic.

A year later, in December 2019, nearly a decade after the Tavistock Gender Identity Development Service (GIDS) began to experiment with puberty blockers on trans-identified children, a young woman called Keira Bell, who had been treated at GIDS as a child and since ‘detransitioned’, and the mother of a female, autistic trans-identified GIDS patient, ‘Mrs. A’, supported by former Senior Clinical Lecturer at the clinic, Susan Evans, brought a judicial review against the Tavistock, in the belief that children are insufficiently developed to understand the long-term effects and repercussions  of ‘gender-affirming’ hormone treatments and surgeries and therefore unable to give their informed consent.

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Part Three

In the run up to the December 2020 verdict of the Bell v. Tavistock judicial review, journalists began to run regular features about the gender clinic’s hitherto unpublicised practices. One concerning revelation was that large numbers of autistic children were being referred to the clinic for treatment. In June, with the media now awash with articles and features about the case, Susie Green, in her position as the CEO of Mermaids – a charity which had, and continues to have, influence over the police and other organisations and was known to coach parents to get the treatments they wanted for their trans-identified children – posted a tweet containing figures relating to the higher prevalence of autistic children experiencing gender dysphoria. An autistic woman replied to Green’s tweet, expressing concern and wondering why large numbers of gender dysphoric children were autistic. Green responded by tweeting links to a paper by and an interview with Dr. Aron Janssen along with the comment, “at the moment there is no consensus on why, research is ongoing”. (Green since deleted her original tweet but the conversation and her response remains online.)

Dr. Janssen is an American child psychiatrist specialising in paediatric transgender ‘affirmative-care’ at the Lurie Children’s hospital in Chicago. He is also Vice Chair of Clinical Affairs in the Pritzker Department of Psychiatry and Behavioral Health and Associate Professor of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine. Much of his research focuses on co-occurring mental health disorders and autism among “transgender and gender diverse youth”.

In the podcast recommended by Green, Dr. Janssen says:

We know that there’s biological constructs that shape gender identity; exposure to hormones in utero influences gender identity and expression, it certainly influences how the body ends up looking.  But then, how that body looks, and how people perceive that body to be, influences how you’re treated as an infant and so, there’s this social construction of gender that happens as well and when any time you’re introducing a social construction piece to a group of folks with autism, you’re going to get variabilities in how that social communication is received and when you have a primary difficulty in social communication and understanding social communication, it’s quite possible folks with autism might construct their own experience of gender in quite a different way from people who don’t.

Dr. Janssen talks around the issue without making clear statements of fact (perhaps leaving room for the listener’s confirmation bias to do the work for him). He states that biology – presumably referring to biological sex – is ‘constructed’. In the contemporary debate about whether sex is redundant as a category and if ‘gender identity’ should replace it, the two categories are generally presented as binaries so it would appear that Dr. Janssen contradicts his statement that ‘biology is constructed’ when shortly after he states that gender is also “a social construct”. He postulates that when a “social construction piece” (whatever that means) is introduced to an autistic person, his/her “difficulty in social communication and understanding social communication” might cause him/her to “construct [his/her] own experience of gender”. Dr. Janssen’s job is to help children make ‘informed consent’ decisions about taking medications, which must be taken indefinitely and which cause serious side-effects and irreversible changes to their bodies. If he is explaining to autistic children that biology is a construct, gender is also a construct and that sex hormones “shape and influence” our gender identities, gender expression and what our bodies look like, could it be that the confusing explanation is as much to blame for the over-representation of autistic people in gender clinics as autistic people’s “difficulty in understanding social communication”?

The same year that Dr. Janssen recorded his podcast, the Gender Identity Research and Education Society (GIRES) responded to a National Health Service England consultation about specialised treatments, specifically regarding the Gender Identity Development Service (GIDS) Specification. GIRES suggested its own specification (in a handy copy-and-paste format) regarding terminology and the future direction of GIDS. Of the significantly over-represented autistic children accessing GIDS, GIRES wrote:

Anecdotally, young people who have been successfully treated [for gender dysphoria], are often described as having no residual [autism spectrum disorder]. The symptoms have disappeared once the dysphoria has been treated. That is obviously not always the case, but it is something that long-term follow-up should address.

This statement implies, despite its many caveats, that ‘gender-affirming’ treatments, such as puberty blocking medication – e.g.: Lupron – can cure autism.

Dr. Spack, who opened the first children’s gender clinic in the US and who has been prescribing Lupron to children since 2007 - when Mark and David Geier were still touting their ‘Lupron Protocol’ as a cure for autism - claimed that treating gender dysphoria can alleviate not only autism but anxiety and depression too. He suggests in this 2018 interview in an article for Boston newspaper, the Phoenix, “maybe the unusual behaviour patterns are simply a coping method for dealing with the anxiety and depression created from living in an ‘alien body,’ as one patient described it.”

Do you remember us asking in Part Two if Abbott Labs would manage to capture the autism-cure market despite Lupron not actually curing autism? Well, we think this might be how they did it.

In January 2019, the UK’s Dr. Mike Webberley (part-owner of private ‘trans-affirming healthcare’ providers, Gender GP, along with his wife, Dr. Helen Webberley, who was convicted of malpractice the previous year) uploaded a video to the Gender GP Youtube channel. In the short video, he is asked the question, “what is your position on the link between gender variance and autism?” His answer is as follows:

I think there is definitely a link between the two. We have a few young people coming through who I would say have high-functioning autism or Asperger’s and they’re often highly intelligent young people who have had previous diagnoses of being on the autistic spectrum. I can’t remember exactly what our figures are but something like 12% of the children we see are on the autistic spectrum.

Dr. Mike’s “position” is that autistic children are over-represented at the service provided by Gender GP. Why that is or whether that is a positive or a negative thing, he does not say. Why Gender GP decided to upload this video is equally mysterious; however, three months later, in April, Dr. Helen held an online symposium, uploaded to the Youtube channel, with visiting US ‘trans-affirming’ medical healthcare professionals Johana Olson-Kennedy and her legal husband (and trans-identified woman), Aydin Olson-Kennedy, with the US-based GP Darlene Tando joining via video-link. During the hour and a half long video, at around the 59 mins mark, the chair asks the panel a question, submitted anonymously by a viewer: “how should we best treat children who say they are trans but are also on the [autistic] spectrum?” Dr. Helen begins by asking disparagingly, “who put them on the spectrum … in the first place?” [The panel laughs.] “It’s … down to that label and that diagnosis, isn’t it?” She opines, “trans kids can find it very difficult to socially interact because their body doesn’t fit, their thoughts aren’t matching, their voice doesn’t fit and… they can often have social difficulties”. She continues, “and so, the young person is saying, ‘I’ve got trouble with my gender’ and the professional is saying, ‘I think you’re autistic’”. Like Dr. Janssen before her, Dr. Helen obfuscates the autistic trait of “social difficulty”, with a gender-dysphoric child failing to communicate his/her gender confusion. She concludes by saying that it is the “[autism] diagnosis … that’s really problematic.” She emphasises the word “diagnosis” disdainfully, as if pouring scorn on the veracity of the autistic condition itself. Dr. Helen’s colleague, Dr. Olson-Kennedy continues in the same vein, stating without evidence, just as GIRES did in 2016, that “there are people whose symptoms of autism go away when they are affirmed in their gender.”

In September 2020, a year after the brazenly autism-sceptic Gender GP symposium, in the wake of the judicial review being brought by Bell and Mrs. A and in a move worthy of a George Orwell story, GIRES added a comment to its response to the NHS consultation of 2016. In the comment, GIRES ‘corrected’ its earlier statement that autism disappears when gender dysphoria is treated, saying that in those cases, "Autistic Spectrum Disorder] has not 'disappeared' as a result of [‘gender-affirming’] treatment: it wasn't there in the first place."

At the Bell v. Tavistock judicial review hearings, GIDS was asked to disclose data it collected about its autistic client base. It shared with the court that:

A significant proportion of all children in GIDS are also neurodiverse and may present with traits of [autism spectrum condition] and/or a diagnosis. Between April 2011 and August 2018, 48% of children and young people who were seen in GIDS and whose parents completed the social responsiveness scale, a quantitative measure of autistic behaviours in children and young people, scored in the mild – severe range.

At around the same time as the judicial review, the beleaguered Gender Identity Development Service faced an employment tribunal from its own Safeguarding Lead, Sonia Appleby, who claimed the service prevented her from proper work on safeguarding and also failed an inspection by the Care Quality Commission, which rated GIDS "inadequate" after inspectors identified "significant concerns". Between 2016 and 2019, while so-called experts in the field flirted with the anti-scientific notion that ‘gender-affirming care’ might also function as a cure for autism, thirty-five members of staff resigned from the service. The wheels were coming off the wagon and the Tavistock’s nine-year experiment with administering puberty-blocking drugs to children (approximately 1 in 2 of whom were autistic) was beginning to look like an unmitigated disaster.

Bell and Mrs. A’s concerns about children’s ability consent to experimental ‘gender affirming’ hormonal treatments and surgeries were eventually upheld by the judicial review. The verdict, handed down in December 2020, mandated that cases of childhood gender dysphoria would require authorisation of the court in future if GIDS believed clinical interventions were necessary. The verdict was later appealed and overturned largely on technicalities; however, what we learned from the case about the Tavistock’s practices (from which we can extrapolate about the practices of other gender clinics), has not been refuted.

In this series, we have focused on Lupron, whose journey from ‘autism cure’ to ‘life-saving gender-dysphoria drug’ to ‘life-saving gender dysphoria drug and possible autism cure’ demonstrates the way in which autistic children have been experimented on by quack doctors and professionals alike for the past two decades; however, Lupron is by no means the only gender-affirmation drug on the market and the net-worth of the ‘trans children’ gender industry, since Dr. Spack’s clinic opened in the US in the mid-noughties, has exploded. Projections of transgender healthcare profits are into the multiple billions and the juggernaut shows no signs of slowing (despite the science on which it is based being about as robust as that of Mark and David Geiers’ ‘Lupron Protocol’) and referrals continue to flood into the Tavistock and Portman Gender Identity Development Service, 48% of which are presumably still for autistic (or those with autistic traits) people.

In 2009, professor of developmental psychopathology at the University of Cambridge and director of the Autism Research Centre, Simon Baron-Cohen, whose theory on testosterone’s role in autism was cited by Mark and Davis Geier in their own papers, was asked by the Chicago Tribune what he thought about giving Lupron injections to autistic children. He said, "the idea of using it with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror", which begs the question: if the UK’s most prominent autism expert believes it would be unethical to give puberty-blockers to an autistic child who has no medical condition, how is it that the Tavistock, Mermaids, GIRES, Dr. Spack and many, many others have got away with it for so long?