Notes on the Journey

Archive for the ‘medical child abuse’ Category

Letter to the Editor: “Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline”

Letter to the Editor: “Endocrine Treatment of
Gender-Dysphoric/Gender-Incongruent Persons:
An Endocrine Society Clinical Practice Guideline”

Michael K. Laidlaw,1 Quentin L. Van Meter,2 Paul W. Hruz,3 Andre Van Mol,4
and William J. Malone5
1
Michael K. Laidlaw, MD, Inc., Rocklin, California 95677; 2
Van Meter Pediatric Endocrinology, P.C., Atlanta,
Georgia 30318; 3
Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri
63110; 4
Van Mol Family Practice, Redding, California 96003; and 5
William J. Malone, MD, Twin Falls, Idaho
83301
ORCiD numbers: 0000-0001-6849-7285 (M. K. Laidlaw); 0000-0003-2831-6480 (Q. L. Van Meter);
0000-0002-1478-3355 (P. W. Hruz); 0000-0001-8678-0025 (A. Van Mol);
0000-0002-5150-292X (W. J. Malone).

transgenderChildhood gender dysphoria (GD) is not an endocrine
condition, but it becomes one through iatrogenic
puberty blockade (PB) and high-dose cross-sex (HDCS)
hormones. The consequences of this gender-affirmative
therapy (GAT) are not trivial and include potential sterility,
sexual dysfunction, thromboembolic and cardiovascular
disease, and malignancy (1, 2).
There are no laboratory, imaging, or other objective tests to
diagnose a “true transgender” child. Children with GD will
outgrow this condition in 61% to 98% of cases by adulthood
(3). There is currently no way to predict who will desist and
who will remain dysphoric. The degree to which GAT has
contributed to the rapidly increasing prevalence of GD in
children is unknown. The recent phenomenon of teenage girls
suddenly developing GD (rapid onset GD) without prior
history through social contagion is particularly concerning (4).
GnRH agonists are used in precocious puberty to delay
the abnormally early onset of puberty to a physiologically
normal age. The goal of PB in the healthy child, however,
is to induce hypogonadotropic hypogonadism to “buy
time” to confirm gender incongruence. In a study of PB in
adolescents aged 11 to 17 years, 100% desired to continue
GAT. They simply “bought” themselves lower bone density
and the need for lifelong medical therapy (5).
Studies show that ,5% of adolescents receiving GAT
even attempt fertility preservation (6). Those started on PB at
Tanner stage II, as recommended by current guidelines, will
be blocked prior to sperm maturation and ovum release.
They will have no prospect of biological offspring while
on HDCS hormones and continuing on to gonadectomy.
The Endocrine Society’s guidelines recommend elevating females’ testosterone levels from a normal of 10 to
50 ng/dL to 300 to 1000 ng/dL, values typically found
with androgen-secreting tumors. The ovaries of women
given testosterone correspond to those found in PCOS,
which itself is associated with increased ovarian cancer
risk and metabolic abnormalities (1). Venous thromboembolism risk is elevated fivefold in males taking estrogen (2).
The health consequences of GAT are highly detrimental, the stated quality of evidence in the guidelines
is low, and diagnostic certainty is poor. Furthermore,
limited long-term outcome data fail to demonstrate longterm success in suicide prevention (7). How can a child,
adolescent, or even parent provide genuine consent to
such a treatment? How can the physician ethically administer GAT knowing that a significant number of
patients will be irreversibly harmed?
Hypothesis-driven randomized controlled clinical
trials are needed to establish and validate the safety and
efficacy of alternate treatment approaches for this vulnerable patient population. Existing care models based on psychological therapy have been shown to alleviate GD in
children, thus avoiding the radical changes and health
risks of GAT (8). This is an obvious and preferred therapy,
as it does the least harm with the most benefit.
In our opinion, physicians need to start examining
GAT through the objective eye of the scientist-clinician
rather than the ideological lens of the social activist. Far
more children with gender dysphoria will ultimately be
helped by this approach.

ISSN Print 0021-972X ISSN Online 1945-7197
Printed in USA
Copyright © 2019 Endocrine Society
Received 5 September 2018. Accepted 20 November 2018.
First Published Online 23 November 2018
686 https://academic.oup.com/jcem J Clin Endocrinol Metab, March 2019, 104(3):686–687 doi: 10.1210/jc.2018-01925
Downloaded from https://academic.oup.com/jcem/article-abstract/104/3/686/5198654 by Washington University, Law School Library user on 23 January 2019
Acknowledgments
Disclosure Summary: Q.L.V.M. is a speaker for Abbvie and is
involved in clinical research with Abbvie on Depot Lupron. The
remaining authors have nothing to disclose.
References
1. Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer
WJ, Murad MH, Rosenthal SM, Safer JD, Tangpricha V, T’Sjoen
GG. Endocrine treatment of gender-dysphoric/gender-incongruent
persons: an Endocrine Society clinical practice guideline. J Clin
Endocrinol Metab. 2017;102(11):3869–3903.
2. Irwig MS. Cardiovascular health in transgender people. Rev Endocr
Metab Disord. 2018;19(3):243–251.
3. Ristori J, Steensma TD. Gender dysphoria in childhood. Int
Rev Psychiatry. 2016;28(1):13–20.
4. Littman L. Rapid-onset gender dysphoria in adolescents and young
adults: a study of parental reports. PLoS One. 2018;13(8):
e0202330.
5. de Vries ALC, Steensma TD, Doreleijers TAH, Cohen-Kettenis PT.
Puberty suppression in adolescents with gender identity disorder: a
prospective follow-up study. J Sex Med. 2011;8(8):2276–2283.
6. Nahata L, Tishelman AC, Caltabellotta NM, Quinn GP. Low
fertility preservation utilization among transgender youth.
J Adolesc Health. 2017;61(1):40–44.
7. Dhejne C, Lichtenstein P, Boman M, Johansson AL, Langstr ¨ ˚ om
N, Land´en M. Long-term follow-up of transsexual persons
undergoing sex reassignment surgery: cohort study in Sweden.
PLoS One. 2011;6(2):e16885.
8. Zucker KJ, Wood H, Singh D, Bradley SJA. A developmental,
biopsychosocial model for the treatment of children with gender
identity disorder. J Homosex. 2012;59(3):369–397.

The Transgender Movement and Bad Stats: A Debunking Compilation

The Transgender Movement and Bad Stats: A Debunking Compilation

It has come to our attention, that, scattered across half a dozen posts, is debunking of a variety of statistics associated with the transgender movement. We fear they may be a little buried in some very long posts. We wondered how to fix this problem. The solution is this article.

Nothing excites readers like the Medium equivalent of a television clip show, which is exactly what this is. We’ve decided to gather all those statistics together in one handy article, so you can reference it in all your online Twitter debates, as God intended.


The US Transgender Survey is a source of many statistics about transgenderism you will find in international policy debates, arguments on the internet, and cited by LGBTQI+ activist organizations. It is run by the National Center for Transgender Equality (NCTE).

It describes its survey to the IRS with the following:

““SURVEY: THE U.S. TRANS SURVEY IS THE NEW NAME OF THE LARGEST SURVEY EVER DEVOTED TO THE LIVES AND EXPERIENCES OF TRANSGENDER PEOPLE. THE USTS IS A SURVEY FOR ALL TRANSGENDER IDENTITIES, INCLUDING TRANSGENDER, GENDERQUEER, AND NON-BINARY PEOPLE, AND WILL BE THE LARGEST AND MOST DIVERSE TRANSGENDER SAMPLE TO DATE. THE USTS IS OUR COMMUNITY’S SURVEY: THE USTS DATA SET AND RESULTS WILL BE AVAILABLE TO COMMUNITY ADVOCATES, ORGANIZATIONS, AND RESEARCHERS FOR YEARS TO COME.” [sic]

The IRS form lets us know how much that survey cost — $318,154. So, what information about the transgender community did $318,154 give us?

We took a look at the lauded NCTE survey, the National Transgender Discrimination Survey(NTDS) which is downloadable from their website, to find out about what information it can give us.

The problem is that the survey, despite its six figure costs, contains numerous methodological flaws, rendering it’s information useless. It isn’t worth discussing what the survey actually shows us, because it is a survey where the sample was built on self-selection. It isn’t random. The survey, which was run online, had as its first question ‘have you already taken this survey before?’, and warned that taking the survey repeatedly would not increase the number of entries into a prize draw (you can view a screenshot here). That meant the survey could have been taken over and over again by the same person. It was also meant to provide US-based statistics, but had no geo-location restrictions. That’s not a valid data-set. That’s not even going to pass an undergraduate statistics course. Supposedly NCTE cleaned the data-set, but I am not sure how you can clean a survey with such flaws. It should only serve as an indicator for further research at best, not a bible or a reason to bring about legislative change. It brings into question every statistic in the survey. Other criticisms were that it tried leading participants into a particular response.

Read more HERE

Radical Feminist: The Equality Act Would Hurt Women

Radical Feminist: The Equality Act Would Hurt Women

 

It feels like conversion therapy for gay children, say clinicians

Thank you Penthesilea Maia Greenleaf for retrieving this article from behind the paywall.

It feels like conversion therapy for gay children, say clinicians

“Inside the clinic rooms of the Tavistock, the private heartache of a new generation of “transgender” youngsters is being laid bare. There used to be about 50 referrals a year, mainly males with a history of gender issues.

Now there are thousands of young females reporting a sudden gender crisis for the first time. Many are convinced that transition – and the powerful drugs that make it happen – will be the solution to their problems.

Until now the specialists struggling to keep up with caseloads have stayed silent, but alarm over the number of adolescents being prescribed body-altering drugs, has prompted five former clinicians to speak out for the first time.

All five have resigned from the Gender Identity Development Service (GIDS) in the past three years as a matter of conscience.
“This experimental treatment is being done not only on children, but very vulnerable children, who have experienced mental health difficulties, abuse, family trauma, but sometimes those [other factors] just get whitewashed,” one female clinician said. “If someone was suggesting plastic surgery or any other permanent change we’d be saying, hang on a minute.”

The clinicians have warned that complex histories and adolescent confusion over possible homosexuality are being ignored in the rush to accept and celebrate every young person’s new transgender identity.

Clinical psychologists carry out each initial assessment at the Tavistock. They are the gatekeepers who decide whether to refer transgender youngsters to the endocrine clinic for the next stage of treatment. Therapists once had months to work through underlying issues before making decisions on medical intervention, but the clinicians claim that young people are now routinely referred for hormone therapy after as few as three hour-long sessions.
They believe that physically healthy children are being medicated in response to pressure from transgender lobby groups and parental anxieties.

So many potentially gay children were being sent down the pathway to change gender, two of the clinicians said there was a dark joke among staff that “there would be no gay people left”.

“It feels like conversion therapy for gay children,” one male clinician said. “I frequently had cases where people started identifying as trans after months of horrendous bullying for being gay,” he told The Times.

“Young lesbians considered at the bottom of the heap suddenly found they were really popular when they said they were trans.”
Another female clinician said: “We heard a lot of homophobia which we felt nobody was challenging. A lot of the girls would come in and say, ‘I’m not a lesbian. I fell in love with my best girl friend but then I went online and realised I’m not a lesbian, I’m a boy. Phew.’”
The specialists expressed concern at how little confusion over sexuality was explored when a young person requested treatment to change their body.

“I would ask who they wanted to have relationships with, but I was told by senior management that gender is completely separate to sex,” a third female clinician said. “I couldn’t get on board with that, because it isn’t. Some people were transitioning their gender to match their sexuality.”

The service said it was “a welcoming place for people from all sections of the LGBT community”, adding that it had made exploration of sexuality a “more explicit” part of the assessment in response to staff concerns.

Nevertheless, the clinician said that her unease grew after meeting an adult woman whose transition to become a man involved having a double mastectomy. She had since changed her mind.

“What can we do? We can’t reverse that. Do we suggest fake breasts?” she said. “We have such a duty of care to these confused young adolescents, but I think we are failing them.”

The clinic rejected the claims. “We always place a young person’s wellbeing at the centre of our work,” it said. “GIDS staff are engaged daily in thinking about the serious ethical dimensions of our practice. The diversity and complexity of individual cases will always be respected.”

Several clinicians suspected that some of the “transgender” adolescents were reacting to homophobia at home.
“For some families, it was easier to say, this is a medical problem, ‘here’s my child, please fix them!’ than dealing with a young, gay kid,” the third female clinician said. At the service’s “family days”, a parent was allegedly heard saying that they did not want their child to have gay friends because they “didn’t want them mixed up in that hedonistic lifestyle”. “It is converting people into heterosexuals,” one of the clinicians said. “We had so many families who would talk about not wanting their daughters to be lesbian.” Young people “repeatedly” confided their own “disgust” that they may be gay, according to the clinician.

In other cases, she felt young people had concluded they were trans because they didn’t fit traditional gender roles.
“Children’s bodies are being damaged in order to treat societal issues,” she warned. She recalled a case of a 13-year-old child “whose parents were really pressurising us for puberty blockers”. When the clinician refused to refer him, she claims one of the parents, a lawyer, wrote threatening legal letters to the service. The child was eventually referred for blockers.

She would have nightmares about her years at the Tavistock. “I would talk about it as an ‘atrocity’. I know that sounds quite strong, but it felt as if we were part of something that people would look back on in the future, and ask, what were we thinking? In the future I think there will be lots and lots of de-transitioners who feel their bodies were mutilated as young people and who will ask, why did you let me do this? It is very disturbing.”

Studies show that the vast majority of youngsters who begin puberty blockers go on to have irreversible hormone treatment at 16. Some go on to have gender reassignment surgery as adults.

All five clinicians expressed concern over how little young people and their families were being told about the impact of hormone treatment on fertility and sexual function as adults. One claimed young people were unable to give “informed consent” because it was regarded as taboo to discuss the impact of medical intervention on later sexual function in such a young cohort.

The clinic said there were no “taboo” subjects in its work, and that it did not “recognise this allegation as reflecting what happens in the service”. It rejected allegations of conversion therapy and insisted that youngsters were being properly advised on the risks of and about what is unknown about medical intervention. Time and care was taken at every stage to ensure that individuals grasped the potential consequences of their choices, it said, adding that the service had become “increasingly aware” of the need to discuss the impact of treatment on future sexual function.

The GIDS’s own internal review identified procedures around consent as an area of concern. It has recommended that written consent should be obtained before referral for blockers.

Another clinician described how youngsters entered his room enthusing about Alex Bertie, a transgender YouTuber, and My Life: I Am Leo, a documentary about a transgender teen broadcast in a teatime slot on CBBC.

“These are very simplified stories about how easy it would be to transition into being trans – that transition is a solution to feeling shit. That is very appealing to lots of teenagers,” the first male clinician said. I felt for the last two years what kept me in the job was the sense there was a huge number of children in danger and I was there to protect them from the service, from the inside.”

One female clinician estimates that she referred about 50 young people for puberty blockers. She now believes she referred too many. Their outcomes remain unclear. “When you start them on puberty blockers, you’re putting them on a pathway that could lead to sexual dysfunction problems and, for the younger kids, will definitely make them infertile. In what other specialism would physical intervention that leads to permanent change to the body be the first line of treatment for a vulnerable child? Activists will tell you it’s unethical not to intervene. But we know that not everyone with gender dysphoria will go on to identify as trans for the rest of their lives.”
One case has haunted her. “All the pushing was coming from the father to put the kid on puberty blockers. Thinking back on it now, I fear that the father was a paedophile and the child was being abused.” There is no suggestion the service knowingly ignored the case, and the outcome is unknown.

The clinic, which is run by the Tavistock and Portman Foundation Trust and whose director is Polly Carmichael, says it is tracking the progress of 44 young people who began puberty blockers in 2011, and that all available evidence is discussed with families. “This is a rapidly developing field and psychosocial and medical professionals are working hard to ensure that we respond to emerging evidence in an appropriate and considered way,” a spokesman said. The growing body of international evidence showed that “thus far, there is little reported evidence of harm,” he added.
“The service undertakes careful assessments over time and continues to see young people whether or not they attend the endocrine clinic following this assessment,” the spokesman said.
The clinic said it was aware of concerns and tensions between different perspectives raised by staff and “clinicians have a duty of care to raise safeguarding concerns”, adding that there were “safe spaces” and structures in place for staff to discuss anything that worried them. It would not comment on specific cases but stressed that a young person’s motivations and choices were discussed at each step.
What began in 1989 as a specialist clinic for gender issues is now under intense scrutiny. A report by David Bell, a former governor at the trust, revealed ethical concerns over “woefully inadequate care”. Staff were furious with the GIDS executive’s response to the report, which stated that its own review found no safeguarding concerns.
The whole service should have been halted when the number of “transgender” cases first exploded, one of the clinicians said. “That’s the point we should have stopped because we didn’t know what we were doing. Are we a service for kids with gender dysphoria, a medical disorder? Or are we a service for ‘transgender kids’?”
A GIDS spokesman said: “We are aware of tensions between different perspectives. These differences are inevitable in such complex work.”
One clinician said it was understandable if her former employer was defensive, saying: “If they are getting it wrong, you have to ask, are they making kids infertile by mistake? Because if they are to truly acknowledge [our concerns], then they will have to ask themselves, what the fuck have we done to thousands of children?”
Gires, GI and Mermaids all denied they viewed transition as a cure-all or that they exerted any undue pressure. Susie Green of Mermaids said the charity “does not encourage parents to demand any particular treatment.” Gendered Intelligence said the allegations against it were “unfounded”. Bernard Reed, founder of Gires, said: “In medical literature, failure to provide timely treatment is described as ‘psychological torture’. As far as we are aware, GIDS has adequate safeguards against irreversible treatments being given inappropriately.”

THETIMES.CO.UK
Inside the clinic rooms of the Tavistock, the private heartache of a new generation of “transgender” youngsters is being laid bare. There used to be about 50 referrals a year, mainly males with a…

Gender Dysphoria The Equality Act and Medically Transitioning Children

Gender Dysphoria The Equality Act and Medically Transitioning Children

Biophobic Thugs Eject Gender Heretics

JULIA LONG AND FRIENDS ACCENTURE TRANS EVENT 21 03 19

Dr. Julia Long

The Tranzborg Are Here, Resistance Is Futile

The Transgender Takeover of Female Sports | Trans Identified Males Beat Women & Girls

They have taken our bathrooms, they have taken women’s homeless and domestic violence shelters, women’s gyms and locker rooms, women’s positions in leadership roles and governance. They are transing & sterilizing our children. They have stolen our ability to name ourselves and are attempting a total destruction of words as we know it as they diligently work to eliminate all true meaning from the words woman, girl, and female. Now, they push for further female erasure as they takeover our sports & steal scholarships and opportunities away from young girls. How one “identifies” is irrelevant to biological sex. To say one was BORN as male can become a female is not only a lie but ignorant, privileged, and delusional. Regardless of what measures of deception one engages in to hide their true sex—such as wigs, fake nails, makeup, clothing, surgery, hormones, prosthetics, etc the biological makeup of a person can NOT be changed. Opportunities are literally being stolen from girls by boys who think they are girls because of the massive amounts of propaganda being pushed out by the mainstream media and funded at least in part by the pharmaceutical industry and backed by government and powerful corporations. Young people are being programmed to believe that if they do not closely uphold the gender stereotypes attached to their sex then they must actually BE the opposite sex. Don’t forget to like, share, & subscribe to help me overcome the heavy censorship of my channel! I was recently deplatformed from Twitter and Instagram. You can find my new instagram account at: thedeprogrammerxx http://www.instagram.com/thedeprogram… My channel is NOT MONETIZED. Any advertisements that run before my videos were placed there without my consent and generate profits for Youtube/Google. The work I do is very difficult (long, excruciating hours editing through stomach churning footage & materials) so any donations to help keep me going are deeply appreciated. You can DONATE via Paypal: womenagainstsexbots@protonmail.com or become a Patron on PATREON http://www.patreon.com/thedeprogrammer Thank you so much to those who have donated and to all those who watch, comment on, and share my videos!

Image result for fox fallon

Tranz, Astroturf and Junk Science

Inauthentic Selves: The modern LGBTQ+ Movement Is Run By Philanthropic Astroturf And Based On Junk Science

By Sue Donym

Let me set the stage for you. It is the recent Anchorage municipal elections. It is cold, it is chilly, it’s Anchorage, and there are municipal propositions: one of them is about local cops being able to issue parking tickets. There’s also Proposition 1 (Prop 1), which attracted $900,000 in spending, dwarfing every other election by a country mile.

What’s Proposition 1?

Prop 1 was put forwajrd by an organization called ‘Alaska Family Action’, and the aim of Prop 1 was to make bathrooms, once again, sex-segregated instead of being based on self-declared gender identity. Anchorage’s bathrooms had been segregated by gender identity since 2015. The left-leaning media reacted in cacophony against this new ‘bathroom bill’, and hundreds of thousands of dollars from reasonable people flowed into Anchorage to defeat a municipal ordinance proposal that would harm trans people. Common sense and reason won, and the liberal project continued, with the rights of transgender people to use the bathroom, re-affirmed.

Except those ‘reasonable people’ don’t exist. Not in any great number.

See, after spending a very long weekend combing through campaign filings from both Alaska Family Action and ‘Fairness for All — Vote No on Prop 1’, it became clear that the vast amounts of money spent on the election by Fairness For All didn’t come from normal, ordinary Americans. Even though transgender people are supposedly a persecuted minority that need civil rights, Vote No on Prop 1 out spent and out raised Alaska Family Action by around $710,000. In total, Vote No had $828,000 at its disposal. Its campaign filings reveal that a large majority of this money came from a set of lobbying groups almost from central casting: The Human Rights Campaign (HRC), Freedom for All Americans (FFAA), Planned Parenthood (PP), and the American Civil Liberties Union (ACLU). Large, federally based organizations poured money and staff into a small municipal election, all to fight ‘bathroom bills’. They flew in representatives from the National Center of Transgender Equality to help with ‘story telling’, and The Transgender Law Center provided consulting services. They made sure volunteers were well fed — ACLU makes many filings throughout for providing catering at events for volunteers. FFAA paid for a slick website, and a subscription to campaigning software Blue State Digital. A local Anchorage ad agency was hired and paid hundreds of thousands of dollars to produce campaign material. Vote No spent as much on campaigning collateral as Alaska Family Action did on their whole campaign, and even more than that on TV ad buys. While there were many small donors, the clear majority of the money came from large organizations, such as Planned Parenthood and the Human Rights Campaign, among others who also provided the Vote No access to their mailing lists and campaign databases, which is also visible in their campaign filings.

Read More on MEDIUM.

Lupron Swag And Eugenic Medical Experimentation on Children

The Lupron Money Trail

Author: 

Recent attention in a dual Reveal and Kaiser Health News Report (‘Kaiser Report’) to the risks of Lupron’s use in children with central precocious puberty (PP) or growth issues, and to Lupron’s risks in general, presents an opportunity to continue the disclosures on the risks of Lupron. This is the fifth part in a 6-part series exploring numerous areas addressing the use of Lupron in the pediatric and teen population. The series began with the voices of the mothers of harmed children and the now-adult suffering children. This was followed by articles on the regulatory issues that surround Lupron’s approval and continued use, the possible reproductive injuries associated with this and other drugs within its class, and issues surrounding Lupron’s metabolism and clearance from the body. Here we will take a look at some of what is known about the Lupron money trail.

Ignoring and Dismissing Side Effects: Follow the Money

WebMD, a highly ranked and promoted consumer ‘go-to’ site for health information, ‘informs’ the public about precocious puberty:  “[t]here’s no evidence that these [GnRHa] drugs cause any long-term problems”. Common neurological and musculoskeletal complaints from Lupron, such as joint and muscle pain, and mood changes are listed as “infrequent” and decreased density of bone as a “rare” side effect. WebMDs “Fertility Drugs” page fails to identify Lupron as a ‘Pregnancy Category X’ drug (as designated by FDA), but states “as many as 50% [with successful ovulation] are able to get pregnant. Most side effects are mild.” Another high-ranking consumer information website, Medscape, tells of a number of clinics “all very experienced in treating gender dysphoric youth … This [GnRHa] treatment is fully reversible.” (See ‘Lupron and reproductive injury’.)

While unrelated to Lupron, the following news story from 2009 was nonetheless thought-provoking: Medscape and WebMD were accused in a whistleblower lawsuit (involving 17 states) of being “part of an illegal conspiracy to promote the off-label use of two [drugs]” – and the details of the charges were “a mystery” due to major redactions by the judge.

Lupron is no stranger to whistleblower lawsuits (here , here, and here) or to charges of promoting off-label uses. The drug’s manufacturer has received ‘Notices of Adverse Findings’ due to its promotion (“indoctrination“) of Lupron for unapproved gynecological indications, and warnings for misleading claims in its prostate indication. The company’s schemes of fraudulent drug pricing and bribing doctors are well known and documented.

CafePharma, an anonymous industry insider message board for pharmaceutical sales reps, had a few postings in 2010 that summed the scenario up succinctly.

“[T]he docs know who has buttered their bread, and we [drug company/sales force] got very deep pockets” (see post of March 20, 2010 @ 12:25 pm here).  And “YOU DUMMY ABBOTT PAYS MILLIONS UNDER THE TABLE SO DOCS USE LUPRON (emphasis in original)” (see post of March 27, 2010 @ 7:45 pm here).

How Lucrative is Lupron Use in Precocious Puberty?

The Kaiser Report identified that in a 2 year period of time Lupron’s manufacturer, AbbVie, had paid $157,066 to the lead investigator of Lupron’s precocious puberty clinical trials, Dr. Peter Lee (a pediatric endocrinologist). According to ProPublica’s “Dollars for Docs”, for the years 20152014, and 2013, Lee received from AbbVie a total of $102,325 for “Promotional Speaking/Other” for Lupron.  (Payments by AbbVie to Lee for Lupron related “Consulting”, “Travel and Lodging” and “Food and Beverage” were not tallied, but figures are available at ‘Dollars for Docs’/ProPublica for each of those 3 years.)

The Kaiser Report also identified that both AbbVie and investigator Lee did not answer specific questions about the omission of serious adverse events (a bone disorder and a pathological fracture) in a key pediatric clinical trial of Lupron. How is this acceptable? If the drug company and lead clinical trial investigator will not answer questions about adverse events in the trial – who will?

In the drug company’s campaign to promote Lupron for precocious puberty (entitled “Too Soon”), they claimed (in 2003) “[t]here are almost 5,200 children who have central precocious puberty and grow up too soon” (see Question/Answer # 10). Lee was a member of the editorial board of “Too Soon”, and Lee is a consultant  for AbbVie, and “has received payment for the development of educational materials by AbbVie”.

It goes without saying that during a promotion of something (especially if one is being monetarily compensated for doing so), such promotion usually results in a loyalty to, and liking for, ‘the thing’.  And especially so if ‘the thing’ is a “cash cow”(stated in a ‘CafePharma’ post of August 8, 2011 @ 3:47 pm).

In 28 months (August 2013 through December 2015), AbbVie made 69,173 payments related to Lupron for a sum of $16.9 million to 24,910 doctors, and Lee came in second place in ‘top doctors receiving payments related to Lupron’.

How objective can Lee and the other 24,909 who are paid by the drug company to promote Lupron be? What would happen if any one of the 24,910 paid Lupron spokesmouths were to say “Hey, wait just a minute … there’s some pretty sick kids (or men and women) out there after using this drug – we need to take a serious look at this”?

Simple logic should tell you that a pharmaceutical company does not spend $16.9 million over a 28-month period to almost 25,000 doctors to hear a negative (bad) message about its product. In fact, I have seen signed consultant and scientific advisor agreements by a rheumatologist with this drug company, and there was a pledge taken to defend the company’s products at all times in all ways (documents presently unavailable, but reference to them was made in my 2003 congressional testimony, p. 12).

It seems peculiar that the #2 recipient of payments for the promotion of Lupron (the use of which spans multiple adult male and female indications that number in the millions) would involve a specialty that serves not quite 5,200 children.

Lupron’s use in the pediatric population is not limited to precocious puberty, and extends to youths and teens with gender dysphoria. Estimates from a federal database in 2016 place the numbers of adults who identify as transgender at 1.4 million (with states ranging from 0.30% to 0.75% of population), but there are no national surveys of youths; small-scale high school surveys have shown about 1.5% of surveyed students identified as transgender.

Pain and Agony of Adverse Effects Is Not a Lucrative Message

In an “ethical dilemma of choosing [between] wrongly suppressing puberty in kids who will grow out of their gender variance or refusing treatment [Dr.] Peter Lee … who had [by 2007] treated three young transgender teens with Lupron, knows on which side he’d rather err” – and that is to administer Lupron/GnRHas. Dr. Lee described one transgender adolescent 20 years ago “in so much pain and agony” that she later committed suicide. (A different perspective has been offered from a psychiatrist who has called this “Lupron treatment [for transgenders] a modern form of child abuse“.)

Where is the discussion on the pain and agony of pediatric (and adult) Lupron victims, and the psychological and psychosocial effects upon the child after development of medication adverse events?  (See Part 1 of this series for excerpts of heart-wrenching pain and agony voiced by parents and victims.) The sudden onset of migraines, weight gain, joint and bone pain, muscular pain, weakness, mobility limitations, mobility impairments, mood changes, irritable bowel, lethargy, difficulties with concentration and memory, anxiety, depression, suicidal ideation, etc., following treatment would indeed have a profound impact upon the child, their relationship to peers, and academic participation.

Given the flood of complaints about Lupron injury that is posted at various online sites, the $64,000 question remains ‘why has the pain and agony experienced by Lupron victims (of all ages and all genders) been so marginalized and often dismissed’?  What causes the reported anger and defensiveness doctors have displayed when queried about the medication adverse effects? (See petitions and medication review site links – the web collectively provides millions of posted complaints, with daily additions.)

Marketing Indoctrination and Coercion

In March 1990 the FDA sent Lupron’s manufacturer a ‘Notice of Adverse Findings’, concerning its “deliberate campaign to promote this product for a wide range of unapproved uses.” A follow-up memo further detailed the FDA’s “concerns” about an upcoming drug company sponsored program at “Walt Disney World Swan”: the FDA said “it appears to be a program to indoctrinate physicians in unapproved uses of Lupron, and to specifically encourage administration of Lupron for these unapproved uses.”  These unapproved uses involved gynecology and fertility. (In October 1990, Lupron received FDA approval for the indication of pain management in endometriosis; no FDA approval for fertility treatment has ever been obtained – and note that Lupron’s initial patent was for ovulation induction.)

As an IVF patient in 1990, my fertility clinic’s brochure stated “Lupron is only prescribed to persons with certain diagnoses”, but in 1991 this changed to “Lupron is widely prescribed”. What would cause the sudden universal use of Lupron at this (and just about every other) IVF clinic?  A 1992 study, which asked in its title whether there was any medical advantage for using GnRHa’s for all patients undergoing IVF, concluded:

“The routine use of GnRH-a for all patients undergoing IVF has practical but no significant medical advantages … there have been very few prospective randomized  studies comparing the use of GnRH-a with conventional stimulation regimens”.

My IVF clinic’s doctors had become indoctrinated to use Lupron in ovulation induction in the same manner as IVF clinics throughout the country. A 1989 US Subcommittee mailed a detailed survey to 224 US fertility clinics to obtain a wide variety of IVF data, and in the process many clinics self-reported their new ‘Lupron protocol’.  These survey responses, and transcripts of an accompanying hearing, were  published in a document titled “Serial No. 101-5” (101st Congress; March 9, 1989).  Here are a few pertinent excerpts illustrating the abrupt change to using Lupron by the survey respondents:

“Changing to Lupron stimulation for all patients” (p. 333. ART Program, Birmingham AL), “us[ing] Lupron for all patients” (p.408. Fertility and Reproductive Health Institute of Northern California, San Jose, CA.), “seventy percent of all patients are administered leuprolide” (p. 417. Century City Hospital, Los Angeles, CA.); “in 1988 we initiated the use of GnRH agonist for all patients” (p. 490. Hoag Fertility Services, Newport Beach, CA.).

Of the hundreds of fertility clinics responding to the Subcommittee survey, only one clinic raised a word of caution:

“Promoting the Use of GnRHa (Lupron) … it remains entirely unclear that all patients need this costly and often painful [and “experimental”] approach” (p.852.  University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ.).

Men, told they otherwise would face treatment for prostate cancer by either castration or DES (and potentially experience gynecomastia and adverse cardiovascular effects) were ‘encouraged’ to use this drug. A survey of urologists revealed that 53% did not believe in the efficacy of GnRHa treatment but still prescribed it.

My 2003 congressional testimony  identifies (p. 7) “the badgering, and coercion, and manipulation, and threats used to convince women into taking Lupron for a variety of indications – many refer to their doctor as trying to “shove it down [their] throat”.

Women were threatened with a hysterectomy (endometriosis), the specter of bleeding to death (fibroids), or refusal to undergo IVF. My 1993 testimony  to the MA. Health Care Committee (an attempt to enact legislation which would mandate fertility clinics provide, among others, accurate information on the risks of Lupron) states:  “… nearly every IVF clinic has mandated that women take Lupron – or they will not be allowed to cycle.”

Parents of children with precocious puberty are ‘encouraged’ to use this drug to prevent the child from ‘enduring psychological distress from their precocious development’ and to ensure achievement of ‘appropriate’ height.  In the transgender population, a similar psychological premise is offered for the normal – but ‘unwanted’ – sexual development, and the specter of anxiety, depression and suicide is raised for the untreated dysphoric youth/teen.

History of Fraudulent Data

In a review of the endometriosis clinical trials’ raw data, Dr. David Redwine discovered that the raw data did not support the claims by the company. In one example, Redwine’s analysis revealed that

“62.5% of women had not regained baseline estrogen levels one year after stopping Lupron … This is definitive evidence of long-term damage to ovarian function.”

Yet, contrary to this raw data, Lupron’s endometriosis label states the effects of Lupron “are reversible upon discontinuation”.  (See p. 26 in amicus curiae for US Supreme Court.) If 62.5% of subjects one year after Lupron discontinuation evidenced long-term damage to ovarian function, then what data did the company provide to the FDA for its 1990 Lupron approval which ‘demonstrated’ its effects “are reversible upon discontinuation”?

In 2010, Dr. Redwine provided a 300-page report to the FDA concerning these instances of apparent data fabrication. The essence of his report, titled “Leuprolide – the ‘D’ is Silent”, can be seen in a somewhat redacted power point presentation here.  Years after receiving the report, the FDA decided “no regulatory action is needed”  – all the while ignoring and failing to address the issue of fraudulent data and altered outcomes delineated in this report.  ‘Lupron Victims Hub’ sent an Open Letter to FDA in 2014 with specific questions – those questions remain unanswered.

During the lawsuit ‘Klein v. TAP, Abbott’, Redwine served as an expert medical witness, and in his expert statement he describes Lupron’s “medical fraud” as being “the most egregious example of Big Pharma controlling the practice of medicine”. Dr. Redwine concludes that Lupron is “unsafe and harmful in addition to being ineffective”.

For further information on retraction of Lupron studies and other instances of problems with the data in Lupron studies, see here,  here , here , here, and here.

Considered Not Related to Study Drug by the Investigator

In the Phase 3 and Phase 4 clinical trials by Dr. Lee for 1 month Lupron Depot-PED, one subject died from respiratory infection and heart arrest. In typical Lupron clinical trials’ language, this adverse event was “considered not related to study drug by the investigator”.  Of the 7 subjects for which serious adverse events were reported, 5 of those 7 subject’s adverse events were “considered not related to study drug by the investigator”.

In another precocious puberty study, the only serious adverse event reported was increased intracranial pressure, and this also was “considered not related to treatment by the investigator”.  While this subject did have a ventricular-peritoneal shunt, it should be noted that Lupron is known to be a cause of increased intracranial pressure. And so it would be interesting to learn how long – prior to Lupron – this subject had a shunt in place without any increased intracranial pressure.  Inclusion criteria for entrance into this study require “general good health with no uncontrolled, clinically significant disease”, and exclusion criteria preventing entrance into this study were “any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk”.  (And note  an unrelated post by a 24 year old woman who developed pseudotumor cerebri “as a result of the poison Lupron”, and who requires a shunt: see July 25, 2011 entry @ 10:38 am here.)

I suppose there could be a number of different reasons for an investigator to consider an adverse event as “unrelated” to a drug, but unless specific questions about the adverse events from these pediatric trials are actually answered — knowing the history of this drug — I can only assume the worst.

Questionable Data Found in Adult Male and Adult Female Studies

MEN: In the mid-1990s, after scouring FDA documents related to Lupron’s initial approval for prostate cancer, it appeared there was curious and questionable data related to Lupron’s cardiovascular effects. At the time, I questioned the validity of the claim Lupron had a safer cardiovascular profile than alternative treatment – a mantra that became a selling point for the drug. (See ‘Was Lupron’s Initial FDA Approval Based Upon Safety & Efficacy’, p. 4-10 here). In 2010 the FDA would issue warnings for Lupron/GnRHa use in men concerning the potential increased risk for cardiovascular problems, heart attack, sudden cardiac death, and stroke (and diabetes).

WOMEN: In my 1995 testimony to the MA. Health Care Committee, I identified “manipulated figures” (p. 8  here) in a female Lupron study – fourteen months before the Federal Register posted a Notice of Scientific Misconduct about the same Lupron investigator/author who had been found guilty of falsifying and fabricating 80% of data in 4 other Lupron studies (2 of which had been published and required retraction).

Illegal Marketing Schemes in Gynecology and Urology

Years ago I was aware of a gynecologist approached by the drug company’s sales force that indicated he could clear $98,000 to his income by prescribing Lupron” (see page 8), and would also find an internal confidential company memo unearthed during Oversight Hearings which detailed for urologists the annual $105,011.40 doctors could earn when they prescribed Lupron.

Bloomberg News summed up the impact drug money had in urology (‘Prostate Patients Suffer as Money Overwhelms Best Therapy’, November 6, 2012.  Bloomberg News;  article snippet  here):

“[In the past] Urologists could make $5,000 per patient dispensing Lupron in their offices, thanks to secret discounts and kickbacks from drug makers.  … In 1997 the 25 top-prescribing Lupron urologists each averaged $1.6 million in Medicare payments. … Two of every five patients who received hormone therapy didn’t need it, the [New England Journal of Medicine] study found. In 2005, after Medicare cut Lupron and Zoladex payment rates by over half, inappropriate use plummeted 44 percent. … Hundreds of thousands of men were chemically castrated for no reason; that’s the biggest scandal of all. … The money was too irresistible.”

There were reports of bribes from Lupron’s sales force in both urology and gynecology, and ultimately

the company pleaded guilty to participating in a criminal conspiracy by providing doctors with free Lupron samples for which doctors then billed Medicare [with] the company inflat[ing] the list price of Lupron to ensure that doctors who prescribed it would make a sizable profit when the government reimbursed them.”

The company paid the then-highest fine in US history – $875 million.

In addition to my multiple  attempts to encourage the US investigation to expand its investigation from financial fraud and into the health risks posed by Lupron, it appears others were also making similar requests: “A call to the U.S, Attorneys Office inquiring whether financial fraud in the marketing of Lupron might indicate that FDA studies may also have been fabricated brought no answer. They are simply not interested.”

Paying the Patient Support Groups

In the past, “[i]n addition to offering inducements to hospitals and doctors, [Lupron’s manufacturer] was encouraging its salespeople to approach patients in support groups” (see herehere, and here ). It is known that the manufacturer of this drug and other GnRHas contributed hundreds of thousands of dollars to an endometriosis support association , and Lupron’s manufacturer also contributed thousands and thousands of dollars to a fertility support group (at a time when Lupron was only FDA approved for men). It is only logical to question whether any pediatric support group(s) experience(d) ‘infiltration’ of Lupron money.

One pediatric group dedicated to growth disorders, the Magic Foundation, is known to have received money from growth hormone manufacturers. According to publicly available documents from Guidestar, this foundation has reported 2014 contributions of $949,348 (contributors’ identity not provided). Appearing prominently (and to me, appearing promotionally), the Foundation’s website discusses and displays Lupron Depot-PED information, as well as providing the web address for AbbVie’s Lupron Depot-PED product information. (Until recently, no other GnRHa was identified, discussed, or linked on the Foundation’s website, and presently one other 12-month injectable, non-Lupron, GnRHa drug is mentioned.)

The information posted on the Foundation’s website of risks from Lupron Depot-PED is quite sparse: there is mention of temporary mood changes, injection site redness and pain, and rarely a sterile abscess, concluding “[r]esearch to date indicates that when treatment is stopped, puberty should resume and advance normally.” “Only as a convenience” does an AbbVie “Puberty Too Soon” website provide a web link to the Magic Foundation. It should be noted that AbbVie’s lead Lupron precocious puberty investigator Dr. Peter Lee, is on the Medical Advisory Board of the Magic Foundation.

Transgender Use of Lupron Noted as Lucrative for Some Providers

A 2013 ‘GenderTrender’ article noted for years “a cluster of extremely well-funded physician providers” have been prescribing to children off-label drugs for transgender use. This article states Lupron is “so toxic” adult transgenders are advised against its use. The article includes a statement by Lee: “Suppression … can be effectively and safely accomplished using GnRHa – an intervention that is both temporary and reversible.”

Benefits of Orphan Drug Status

Lupron for use in precocious puberty (a rare ‘orphan’ disease‘ which by definition affects less than 200,000 in the US) has the designation of “Orphan Drug” status, allowing the drug company tax credits (under 26 USC 45C) for related clinical testing expenses (see here and here). It should be determined if expenses from non-precocious puberty pediatric uses (which would be ineligible for orphan status/tax credits) have been filed, i.e., transgender and acne (which affects approximately 1.4 million and 50 million people, respectively). How many off-label, unpublished studies have been conducted in the pediatric and teen population?

Lupron is Lucrative

Based upon the information provided here (and this is not an all-inclusive list), in my opinion it seems little wonder that Lupron became the most prescribed GnRHa, became prescribed for men, women, and children (and animals, fish, chickens, etc.). And it’s no surprise why Lupron has been prescribed for A – Z off-label indications, nor why its victims have met with extreme difficulty in having their adverse events acknowledged and addressed.

Lupron has not only been lucrative for a number of its opinion leaders, spokesdoctors, and prescribers – it has also resulted in a cottage industry born from Lupron-induced iatrogenic injury, requiring acute and chronic office visits and hospitalizations for virtually every practice in medicine (neurology, rheumatology, cardiology, endocrinology, oncology, gastroenterology, psychiatry, pulmonary, dermatology, etc.).  This drug isn’t just a “cash cow” – it’s a “cash pig”.

Postscript: Correction

April 25, 2017 – The above is an edited version of an article that was originally published on April 18, 2017.  In this edited version, information pertaining to adverse events in one particular pediatric clinical trial has been removed from the original article because this information has been learned to be inaccurate.  In the original article, I cited adverse event numbers as found listed within this pediatric study’s results.  However, in looking at this study’s list of adverse events, I read (and cited) the reported numbers that followed any particular adverse event – when, in fact, the correct reported numbers were those that preceded any particular adverse event.  This list’s reverse order of coding resulted in my (erroneous) conclusion that the numbers of adverse events reported for this trial were in error.  (And the list, when read in reverse, provides reported adverse event numbers that exactly match those reported in this trial, indicating no error had occurred.)   I have emailed the author of this pediatric study an apologetic note, describing the confusion that resulted from this list’s atypical coding methods, and have acknowledged that the reported adverse event numbers for this trial are indeed “valid”.  I apologize to anyone else who may have been inconvenienced by this error.

The original (and now known to be erroneous) text removed from this edited version is included here for your information:

Original Text

CHILDREN: And now, after looking closely at one pediatric clinical trial, there appears to be clear evidence that larger numbers of adverse events were experienced by these children which were not recorded or identified in the final results of this study.

In this pediatric trial, my review counted six adverse events which did not contain the correct number of reported adverse events in the final study results. For purposes here, one adverse event – vomiting – will be used as an example to describe this inexplicable disappearing act of adverse events.

The medical journal publication of this clinical trial, and the ‘study results’ of this trial (housed at ‘ClinicalTrials.gov’) both claim there were “0” reports of “vomiting” in Group 1 (3-month Lupron Depot 11.25 mg) and “4” reports of vomiting in Group 2 (3-month Lupron Depot 30 mg). However, in looking at the history of this trial at ClinicalTrials.gov, which identifies the changes and additions made to this trial, it can readily be seen that the changes made on December 9, 2013 (the additions of reported adverse event numbers) display that for the adverse event of vomiting, Group 1 had “10” reports of vomiting, and Group 2 had “9” reports of vomiting. That is a significant difference in numbers of reported vomiting than is found in the journal publication and in ClinicalTrials.gov study results. And when these documented (but not counted) adverse event reports of vomiting are properly tallied, the claimed incidence of vomiting changes from the published 5.6% to an actual incidence of 26.4%.

In emails to the lead author in attempts to learn the explanation(s) for these missing, untallied adverse events, I was informed that the data as published in the medical journal “is valid” and he is “not the responsible person for this data.” Numerous attempts to learn exactly who is responsible for the data in this clinical trial have proved fruitless to date. How can the lead author not be responsible for the validity of the data from his own study?

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Peak Tranz/Pique Resilience

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