Notes on the Journey

safe_imageA complication, ‘crazy pain,’ as South Florida trans teen Jazz Jennings gets confirmation surgery

 

TLC’s “I Am Jazz” has been chronicling South Florida trans teen advocate Jazz Jennings’ life-changing journey of getting her gender confirmation surgery for the past year.

“Having my whole family with me throughout this entire journey has been so important,” the 18-year-old said in last week’s episode of the show which showed the first part of her surgery. The second part aired 9 p.m. Tuesday. “From the beginning they have just provided me with unconditional love and support and the fact that they’re here on this day just signifies that we’ve come so, so far since the beginning of this journey. This is really the final step, this is the final transition, and I’m so glad that I have them by my side.”

Read more here

Charlie Rae said:
There was a thread on twitter which detailed, scene for scene, the horrors of Jazz Jenning’s nationally aired recording of his pre and post-mutilation. The thread looks like it has been taken down but I happened to have copied some of the text to put in over at The TERF Exhibit.

Watching the videos were brutal. If you didn’t see, he came out in a lot of pain, continually wincing and groaning, he is having a hard time peeing, he has some kind of a blister, his stitches might come apart, and there were enough complications that he had to be taken immediately back to the hospital. They also aired a shot of the boy’s face as the doctors dilated his wound for the first time. My stomach is actually turning as I write this. This child abuse needs to end. Here is most of the text from the tread that was taken down:

“Context. This person has been suffering under this fake ideology since a child. Was put on drugs. And didnt have enough “meat” to make a “normal” sex change happen. So they did experimental surgery.

The surgeries are BRUTAL. Plastic surgeons do these but the reality is its mutilation. Its moving parts of the body to where they do not belong to create something that isnt real or functional. Complications are nightmarish and end in suicides often.

Dilation is the forcing open of the open wound that is created during the “creation” of a “vagina” with rods. You have to do it constantly multiple times a day. For years. This alone ruins lives and leads to suicide and regret

Here is a dilation chart and a chart on how “usable” a newly created vagina is over time and hygiene regimens. A year of unending pain , boredom and inactivity. Many suicides come from the first year due to this brutal regimen.

Medical complications are not just immediate. While there is chance of entire loss of the “new vagina” via necrosis. There are other things like the stream of urine being permanently disturbed. Meaning a mess all over yourself every time u go pee

While the producers chose silly upbeat music to cover this up. The reality is this scene is a realization of something that wont ever go back to normal. This person likely is never going to have a normal pee again.

And just 36 hours later disaster strikes. Because this is not a normal surgery. Complications are often NORMAL. You are cutting off skin and re-attaching it other places. In this case , loss of bloodflow would cause necrosis. Skin death

Do not hate these people. They are victims of an ideology that is spreading like wildfire. The best thing you can do is educate yourself about this and contact your representatives. These surgeries are a crime against humanity.”

Our Friends On The Left

“Our friends on the left are afraid to talk about the fad of the sterilization of minor children for sex stereotype nonconformity, as often determined by children’s preferences in 21st Century toys, clothes, and hairstyles. That’s because our friends on the left are worried that they’ll get fired or shunned by their unthinkingly neo-eugenicist neighbors, whose ideological forbears employed castration, hysterectomy, clitoridectomy, and primitive brain surgeries, that all attempted to cut the sex drives out of the wayward and deviant. The conservative women who stand with us share in our genuine horror at the idea that the modern “cure” for strongly deviating from sex-stereotyped behavior as a child should be the chemical sterilization or surgical removal of one’s genitals before adulthood.

Indeed, most reasonable people likely agree that castration, chemical or surgical, is a disproportionately harsh consequence for being a little boy who likes to play with dolls and costumes that Disney and Mattel decided to market only to girls. Similarly, mastectomies and hysterectomies seem like an extreme penalty for being a girl who likes dinosaurs, superhero stories, Legos, and clothes that are suitable for an active lifestyle.

We’re baffled that anyone thinks cosmetic genital alteration is a good option to offer young people. But here we are, in a country where such surgeries are prescribed as a treatment for unhappiness or eccentricity to people too young to drive, vote, or be allowed to buy alcohol. Our friends on the left consider it dehumanizing to children to take away their innocence by holding them to adult levels of responsibility when it comes to school conduct or legal infractions, but not dehumanizing to let them choose permanent sterility. How does that make sense?”

—Women’s Liberation Front

ANONYMOUS SISTER SEZ:

‘LESBIAN’ IS A SEXUAL ORIENTATION, NOT A “GENDER IDENTITY”

I recently read a statement made by a male transactivist that lesbians should have to ‘prove’ that they are lesbians. He further posited that there is no way to ‘prove’ it. So they must just be ‘transphobic’ and must be ‘obsessed with genitals”. The irony is that he is a straight male just spouting what straight males have harassed lesbians with forever. That women should be raped. All women. And that they just need dick and they’ll be somehow ‘fixed’.

Gays and lesbians are exclusive because they have a same-sex orientation. Stating that they have to accept the sexual advances of the opposite sex stems from rape culture and is homophobic. But that’s what transactivists are saying. They are suggesting that lesbians are focused on genitals and that that is ‘transphobic’. While there really isn’t such a phobia as ‘trans’, it IS homophobic to even imply that a homosexual cannot have a preference for a same sex partner.

Keep in mind that the language of transphobia is stemming from oppressors—overwhelmingly they are the straight, white, entitled male autogynephiles who are pushing for the rape and torture and erasure of lesbians.

Homosexuality is a sexual orientation. WE don’t have the privilege to identify in and out of our orientation.

Gay and lesbian terms indicate ‘same sex’ orientation and this doesn’t have to be ‘proven’ as some transactivists are now suggesting—any more than a heterosexual has to ‘prove’ their sexual orientation. We don’t have to be ‘inclusive’—because same sex, by definition, IS exclusive of the opposite sex.

Lesbian or butch is not a gender identity that one puts on and off on a whim. Homosexuality is not an ‘identity’. People keep conflating gender identity with sexual orientation. Gender dysphoria is a subjective feeling in one’s head. Sexual orientation is not.

It enrages me in this blatantly homophobic culture that so many liberal and middle-of-the-road ‘progressives’ actually think to harass and bully and abuse lesbians who have extremely low status in the grand pecking order, by virtue of being women who love women in the first place. And the abuse is coming from straight AGP males. How is this not obvious?

I mean, what sane woman would ‘choose’ to be bullied, abused, bashed, lose jobs and promotions, be raped and publicly scorned for loving a woman? What woman would choose to be unable to hold her lover’s hand in public, to have to refrain from sharing stories of romance at work and to be unable to disclose aspects of her life for fear of retribution? Homosexuality is an orientation I did not choose and one I cannot identify out of when it suits my narrative.

No, I don’t have to fucking ‘prove’ that I am a butch lesbian to any man. I owe no explanation for who I am, who I love and how I live. Transactivists, genderists, queer theorists, pomo adherents and identity politics fuckers be damned.

A communist at large

With law changes pending in the UK, New Zealand and other places that will make it simpler for people to change the sex marker on their birth certificates (and moves in the opposite direction apparently being discussed in the US government circles), scientists have waded into the debate on transgender ideology. They are not shy about waving about their scientific credentials as they attempt to answer what is fundamentally a political rather than a scientific question. And in doing so, they are not only joining an assault on women’s rights, but also doing a great disservice to scientific thinking. You don’t have to be a scientific expert to see this.

Dr Siouxsie Wiles

Siouxsie Wiles is an Associate Professor in Molecular Medicine and Pathology at Auckland University, who popularises scientific ideas in various media including Radio New Zealand and Stuff. She published an article  on Stuff 26 November is headed

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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.

“While the location may be wholly incidental, it places breast removal and the transitioning of the feminine to the masculine at the heart of a book for girls about breasts. Some women may interpret this material realisation as another example of how we hate women. Breasts are front and centre of a woman’s anatomy and a double mastectomy is placed at the geographical centre of the entire book. It is ironic that the core of the book is symbolically empty of breasts. The feminine breast themes are symbolically moved to both sides of a male chest narrative that centres masculinity at the expense of femininity and male attributes over female attributes. Placing this simplistic version of a complex narrative within a raging debate around self identification serves the needs of gender self identification advocates more than it does the needs of girls.”

Full Cream

This commentary on The Breast Book is a guest post from Eufemia Torres. Eufemia is a qualified teacher from the UK and a mother of two breastfed children. She has a keen interest in the politics and social issues.

This article is not intended to be a book review. The commentary is centred on chapter four with some references to other information within other sections, and the wider social context in which this book resides.

The cover of Emma Pickett’s new book, The Breast Book, published by Pinter and Martin 2019 is subtitled “the puberty guide with a difference – it’s the when, why and how of breasts”.  Eagerly anticipated by a demographic that has sought out previous titles by Pinter and Martin, The Breast Book promised to be a counterpoint to the sexualisation and objectification of women’s bodies that girls may already be facing, even at the age…

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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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A Moment In Herstory

This is from my time. This is herstory that I lived. If you know your herstory, then you will know where you’re coming from. And – Bite Me,  you privileged third wave pomo jerkwads, you know fuck all.

Catharine Russo Documentaries

53894697_2557037167643772_905717016843780096_o.pnghttps://www.piqueresproject.com/

https://twitter.com/piqueresproject?lang=en

https://www.patreon.com/piqueresilienceproject

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Lesbian Feminist: Trans Is a ‘Misogynistic Trojan Horse’

BY TYLER O’NEIL MARCH 7, 2019

On Thursday, lesbian feminist Julia Beck testified before Congress against the gender identity provisions in the Violence Against Women Act (VAWA). Meant to protect transgender people, these provisions actually act as a “misogynistic trojan horse,” undermining key protections for women and girls, Beck argued.

“The first piece of U.S. legislation to even acknowledge the epidemic of violence against women is now a misogynistic Trojan Horse,” Beck declared. She argued that “all women and girls are oppressed on the basis of our female sex,” not their gender identity.

Beck herself recalled facing threats of violence due to her opposition to transgender activism. “People on the Left have tried to silence me by using threats and other tactics of intimidation, a kind of hatred that most lesbians would expect to receive from people on the Right. I’ve been told to die in a fire, to get raped, and to choke on ‘lady c*ck’ by members of the GBT community,” she said.

“My so-called allies cast me out for speaking about male violence, so I spoke with the only people who were willing to listen, people on the Right, who usually never see eye to eye with lesbians or feminists,” Beck explained, referencing her appearance at the Heritage Foundation in January.

She praised the Violence Against Women Act (VAWA) as a critical protection for women and girls facing violence but warned that when gender identity provisions were added in 2013, that undermined the very purpose of the law.

“The distinct sex categories of female and male are mutually exclusive. Therefore women and girls benefit from female space,” Beck said. “In its earliest forms, VAWA defended female space.” In 2013, however, “one small addition to the act dissolved all of its sex-based provisions. VAWA now protects the nebulous concept of gender identity, defined in Title 18 as actual or perceived gender-related characteristics.”

Beck argued that protections based on gender identity are “illogical and completely irresponsible.”

“While sex is a vital statistic, gender and identity are not. VAWA was created for women and girls, not for those who feel like or identify as female. Woman is not a gender or a feeling,” Beck declared. She undercut the entire gender identity concept, attacking it as sexist. “No one has ever been able to explain what ‘feeling like a woman’ means without using sexist stereotypes.”

“Women don’t need to identify as female in order to be women,” the lesbian added. “Woman means adult human female. New gender identity laws allow male people to claim womanhood.”

“The Violence Against Women Act has become the Violence Against Anybody Act,” she quipped. “Its original sex-based protections are now meaningless because men with gender identities who commit violence against women are protected by federal law. When gender identity wins, women and girls always lose.”

The lesbian argued that those who think “gender identity is the next frontier of social justice … couldn’t be more wrong.”

“Gender is based on rigid sex roles and superficial stereotypes that legitimize male dominance and female subordination. This harmful hierarchy is something that women and girls can never ‘identify’ out of,” she explained.

Violence against women around the world is horrific and cannot be explained in terms of gender identity. “Female fetuses cannot identify out of sex-selective abortion. Global majority women cannot identify out of genital mutilation or forced impregnation,” Beck added, mentioning three of the worst abuses faced by women around the world.

“Women and girls are targeted by men because of our female sex, because the doctrine of gender codes females as subhuman,” the lesbian argued. Transgender identity buys into that “doctrine of gender” and throws a “misogynistic Trojan Horse” into the very law intended to defend women and girls against sex-based violence.

“One of four girls will be sexually abused before they turn 18 years old and 96 percent of people who sexually abuse children are male,” Beck said. “Half the population is living in a state of emergency. Violence against women is a hate crime, but as of 2013, it is state-sanctioned, as long as perpetrators ‘feel like’ they’re women.”

The lesbian concluded her testimony with a call to action. “Everyone here, whether you’re female or not, knows what a woman is. Everyone knows that violence against women is a sex-based issue,” she said. “So for the sake of women and girls, please remove gender identity from VAWA.”

Follow Tyler O’Neil, the author of this article, on Twitter at @Tyler2ONeil.

49667095_1592497384229229_3670532489144696832_oSo this is going on right now at my library. I didn’t attend for two reasons, 1. because I was meeting with Rep Loebsack to talk to him about The Equality Act and gender identity and because 2., I have problems with men calling themselves lesbians and I was concerned that I might out myself as gender critical and be ousted by the group. I had a good talk with Rep. Loeback about gender identity and then came here to the library to access their computers. When I walked thu the doors, women were milling outside the conference room and the first person who caught my eye was the transgender d00d who sexually assaulted my daughter when we all lived at the River City Housing Coop here in Iowa City. This young man is a seriously disturbed individual with a morbid fixation on his mother’s death. He is a man who is pretending to be a woman. Instead of confronting this kid and making him deal with his issues, people are enabling his personality disorder and gaslighting women into accepting him as a woman. He is a privileged man who abused my daughter sexually, but who gets away with it because my daughter is too bamboozled to realize she was sexually assaulted by a MAN. I am so pissed off right now. 

Midwest Intergenerational Lesbian Conference 2019

 

downloadThis is a talk that I gave at the Iowa City Senior Center on transgenderism and the connection between cross-dressing billionaires and the mutilating surgeries that are being sold to confused kids. I draw attention to how this fad is manifesting here in the Iowa City community.

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