Notes on the Journey

Lupron Victim Advocate Issues Urgent Warning

lupron-11.25-mgNovember 11, 2019

It seems that my body is slowly decomposing, and I feel like a hobbled, twisted ruin in agony. My medical records describe me as a “frail, cachectic, chronically ill appearing woman who appears older than stated age.” Because of exhaustion and my accelerated mobility impairment and health decline over these last few years, I’m taking a doubtful view on my longevity.  And these thoughts leave me with many concerns, one being the possibility I could leave this world before being able to put a lot more information onto my website.

Before taking Lupron in 1989, I was a healthy 32 year old woman. I was gainfully employed, physically vibrant and very active. I took daily Lupron for only 9.5 months:  6.5 months in 1989 for ‘treatment’ of endometriosis, and a total of about 3 months during several IVF attempts in 1990 and 1991. I tried refusing Lupron for IVF, but was told that I “must” take it. Women in the past often reported that their doctors were shoving Lupron down their throats. In this era and context, these women did not want or seek or request Lupron.

Although the progression since the ‘90s was gradual, today I am a physical wreck and carry the diagnoses of, among others, severe osteoporosis, moderately severe scoliosis, and moderately severe kyphosis (causing shortness of breath). My spine has become so twisted that the deformity is now obvious to any casual observer. This deterioration has accelerated greatly over the past five years, and now I’m often nearly incapacitated from severe pain and impaired mobility. Only very recently did I discover a January 1991 X-Ray that showed the onset of mild curvature of the spine – a condition I did not have during Boston elementary school screenings nor during early adult life.

In 2003 I had to retire on a medical disability from my nursing career with the VA due to Lupron-induced destruction of the neurological impulses to my gut, causing severe gastroparesis (paralysis of stomach and intestines). This condition has resulted in 64 hospitalizations since retiring, and I continue to experience frequent gastroparesis episodes that now can be mostly managed from home.  The neurological impulses in my heart have also been affected, and I have EKG readings of 38 beats per minute, as well as recordings of numerous lethal cardiac arrhythmias. The list goes on and on, and includes (but is not limited to) arthritis, cysts (breast, kidney, tonsilar), myofascial pain syndrome, major dental problems (from Lupron-induced bone loss), episodic liver abnormalities, atrophy of pancreas (mild), development of an “atypical” gallbladder tumor within a year of stopping Lupron, etc., etc., etc.

In preparation for my 1995 testimony in support of ‘my’ bill to mandate written informed consent of the risks of Lupron, I typed on continuous, single-spaced, computer paper a chronology of every doctors visit, lab, test, procedure, and surgery that I had had in the then-6 years since Lupron exposure.  At this 1995 hearing, I unfurled the somewhat dramatic results – a piece of paper that was seven and a half feet tall.

Immediately following my testimony, another Lupron (IVF) victim testified in support of this bill – and there were gasps in the room as she removed her wig to reveal a totally bald head.  She went on to relay how she did not have one hair left on her body.

Despite all my health problems post-lupron, I remain acutely aware (and very thankful) of the wonderful life I’d been able to lead pre-Lupron. But these kids being exposed to Lupron for transgender ‘therapy’ have barely started living, and to literally stultify them is heartbreaking.

My abilities and productivity have been so curtailed because of continued poor health and increasing pain with mobility limitations. And so, I wanted to send this note so the Kelsey Coalition and trans youth would know more about the dangers of Lupron from someone who has researched, lobbied, and worked with its victims for decades.

For years, I’ve been saying that there needs to be an army of people working on “this” – meaning working towards acknowledgment of Lupron victims, compel admission of the serious and irreversible adverse effects, create study of victims, and arranging treatment, support and medicolegal advocacy for victims.

Instead,  there has been an ‘army’ that has developed to ensure transgender youth gain access to Lupron/GnRHas – and they have systematically promoted Lupron as safe and reversible treatment that can avoid trans-associated depression and suicide.  Virtually all ‘soldiers’ in this army deny or diminish Lupron’s risks, all ignore or dismiss the mass of Lupron victims, and none will tell the prospective patient or parent that Lupron has a known history of causing depression and suicide. Academia, medicine, psychologists, social workers, all kinds of LGBT advocacy and support groups raise awareness of ‘the need’ for “puberty blockers/suppression”, law firms and legal groups muster pro bono legal challenges to denial of care, courses are being taught to healthcare workers, and at least a dozen states and Washington DC have enacted Medicaid coverage of transgender medical and surgical therapy.

For decades I’ve been contacted by men, women, and now-grown children who consider themselves victims of Lupron, and who’ve been desperately seeking help – usually both medical and legal.  I’ve heard from victims in 14 other countries besides the U.S. These people were prescribed Lupron for a wide variety of indications – i.e., precocious puberty, endometriosis, IVF, fibroids, egg donation, surrogacy, breast and prostate cancer, among others.

There is ample information on Lupron’s risks.  Everyone needs to beware that once exposed, there’s no going back.  To quote Lupron’s ‘Material Safety Data Sheet’:  “[t]here is no known antidote” (see “Emergency & First Aid Procedures”).

A few interesting Lupron author/investigator tidbits:

As a minor example of information not yet posted on my site, the Kelsey Coalition has a link to an April 2018 study of ‘Lupron in adolescents with endometriosis’ on its “First, Do No Harm” campaign page.  I had not seen this abstract, and was shocked to see that Dr. Marc Hornstein was a co-author of an article identifying risks of Lupron.

Hornstein was one of my treating physicians and he was the physician cited in my 1995 MA. Health Care Committee testimony and my 2003 congressional testimony who told me I “must use Lupron if [I] want[ed] IVF”.   In 1995 Hornstein, as President of the Boston Fertility Society, submitted testimony in opposition to a MA. bill I co-drafted which would have mandated written informed consent of the risks of Lupron (and other fertility drugs) within the fertility clinic setting – i.e., see “Section 4:  Section 15 a & b” in bill.  Hornstein testified this MA. bill “duplicates significantly” a federal bill (Public Law 102-493) and was therefore unnecessary – yet the Public Law was completely devoid of any provision for informed consent, while the MA. bill delineated the requirement for written informed consent of the risks.

Neither Hornstein nor the Boston Fertility Society wanted a mandate requiring written informed consent for the risks of Lupron (and other fertility drugs), and the bill eventually died in 1999.  To see Hornstein listed as co-author of this April 2018 article identifying serious risks of Lupron is surreal – he had been so adamant in 1990 that Lupron was great and Lupron could not have caused my post-lupron health problems.

Hornstein also was the co-author of one of the several retracted Lupron articles whose lead author was Andrew J. Friedman (who was one of my covering IVF physicians).  In the Federal Register’s notice of Friedman’s fraudulent Lupron articles, Hornstein’s name is curiously omitted, with a nurse practitioner’s name inserted in Hornstein’s place.  As a result, Hornstein has never been associated with this fraudulent Lupron research/publication.  On my website, in attempts to correct this ‘error of omission’, I’ve reprinted the Federal Register’s notice but have appropriately inserted Hornstein’s name where it belongs. When I wrote the Federal Register to report this error, their reply was “sorry for any inconvenience this error may have caused you” and no correction, to my knowledge, was ever made.

Similarities in Transgender / Infertility Agendas:

It is frightening to see the agenda-driven group-think coming from all the professionals.  I see parallels in the push and rush to use Lupron in transgender youth with the early push and rush to use Lupron in IVF for infertility.  For example, the sudden adoption of Lupron use everywhere, taking it from a virtually non-existent ‘modality’ to a standard and accepted treatment;  the lack of disclosure and suppression of risk information; an ideology promoted as science while lacking any scientific study; and the ‘business’ is lucrative – and not without conflicts of interest.

For one example illustrating the early flood of Lupron into fertility clinic use, 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” (House of Representatives, 101st Congress, First Session; March 9, 1989).  Of the hundreds of fertility clinics responding to the Subcommittee survey, only one clinic raised a word of caution, stating “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.).

“Hazardous Drug” Classification:

Whether Lupron is being prescribed for infertility, transgender, or any of the other myriad off-label uses, consumers are not informed of Lupron’s (aka leuprolide) “hazardous drug” designation by OSHA and NIH.  Lupron’s product label does not identify in any way, shape, or form that Lupron is categorized as a “hazardous drug”.  How many transgender youth in Lupron ‘treatment’ receive their injection by a gowned, gloved, and goggled healthcare worker?

Consider the startling implications of the following declaration:  In the event of a leak or spill of Lupron “the procedure to be followed is to Evacuate area”, and personal precautions are to “wear respirator, chemical safety goggles, rubber boots, and heavy rubber gloves.” Lupron also is a known reproductive and developmental toxicant.  It just makes no sense to declare that if Lupron is spilled on the floor everyone should evacuate, yet also claim when Lupron is injected into a youth/teen’s body it will be ‘beneficial’.

Fraudulent Data Within Lupron Depot 3.75 mgs clinical trials’ raw data:

One of the most serious and distressing of all issues related to Lupron is the issue of fraudulent data and altered outcomes, including (but not limited to) the submissions to the FDA for the 1990 FDA approval of Lupron Depot 3.75 mgs (for endometriosis).  This 3.75 mg dosage and formulation is the one I’ve seen most often recommended for “puberty suppression” in transgender youth.

The Kelsey Coalition should become familiar with the details of this very disturbing situation.  For a brief summary, please read my  September 2019 letter to FDA requesting they address this most alarming and critical issue, and see also ‘Hidden Clinical Trial Data about Lupron’.  It is vital for the transgender population who will be prescribed Lupron Depot 3.75 mgs to understand there are valid and credible reasons to believe this dose/formulation was FDA approved based upon company-submitted data that has been demonstrated to contain fraudulent data and altered outcomes.  Everyone should be asking this question:  ‘Why are the clinical trials’ data for Lupron Depot 3.75 mgs under a court seal and unavailable for inspection?’   This raw data has been sealed from view for a reason.

Successful Legal Machinations Thwart Litigation, Yet Perjury is a Felony:

AIDS activists have a history of organizing protests against Abbott and AbbVie (respectively, the past and present manufacturers of Lupron), and have mobilized for issues such as drug pricing and business tactics.   Both the gay and straight community should be absolutely outraged over the crooked community that prevailed in pulling off the nefarious shenanigans orchestrated by Abbott in the only Lupron product liability lawsuit to make it to trial, the ‘Klein case’ (involving Lupron Depot 3.75 mgs).

There has been an incredible miscarriage of justice in this case, with serious consequences that have societal ramifications.  Perjury is a felony, yet Abbott’s paid medical expert (who’d been a paid Lupron investigator) blatantly lied to the jury, adamantly denying the documented and known risks of Lupron.  This felonious fabrication was done without any judicial, medical, or lay notice.

As a result of this perjury, the Klein jury found in favor of Abbott – and in doing so brought to a screeching halt the lawsuits that were waiting in the wings.  Had Klein’s jury been given accurate information about Lupron’s documented adverse effects instead of lies, and were the jury to have found in favor of Klein, then the floodgates would have opened and it is highly probable that a Lupron class action lawsuit would have been formed shortly thereafter.

Klein appealed her case to the US Supreme Court, and when no one else would, I filed a pro bono amicus curiae brief to the Supreme Court on behalf of Klein and similarly situated individuals.   In my opinion, since the US Supreme Court refused to hear the Klein case, it would appear that medical experts can commit perjury about the known risks of Lupron (or any drug or device) to any jury, mislead them, cause a bad verdict and a horrifying miscarriage of justice — and there is no accountability and no consequences to the perpetrators (other than effective shielding from liability, and protection of profits). This is so incredibly wrong.

Lupron’s manufacturer is a known “criminal enterprise”:

Consider these facts:  In the only Lupron product liability lawsuit to make it to trial (all others settled with secrecy agreements), which involved the 3.75 mg formulation, the clinical trials’ data for this drug is concealed by a company-sought, court-ordered seal.  And given the blatant perjury on the stand by a paid ‘medical expert’ (with a documented conflict of interest), it can be presumed the company suborned perjury to nix the Klein case and avert future litigation.  (And they were entirely successful.)  For further atrocious examples of this company’s ethos (including concealment of adverse data in other drugs), see my website’s ‘History page’.  For further information regarding retracted medical journal articles on Lupron, or regarding questionable Lupron clinical trial data, see herehereherehere, and here.

A window into the soul of the company was revealed when Abbott emails were subpoenaed by the Senate Finance Committee related to its 2010 investigation into Abbott’s cardiac stent “business strategy”.  Because of a Baltimore Sun journalist’s negative (accurate) reporting on Abbott’s stent machinations, Abbott’s emails revealed this ominous comment:  “Don’t you have connections in Baltimore????? … Someone needs to take this writer outside and kick his ass! Do I need to send in the Philly mob?”

Bear in mind this company was deemed a “criminal enterprise” following its settlement with the US government for $875 million in 2001 (the highest fine in history at the time) – for marketing fraud.  Although I provided evidence raising the issue of health risks of Lupron to the Boston US Attorneys’ office at the time of the lawsuit, Lupron’s adverse health effects were not addressed within these proceedings.  (The documentation in the latter link contained discussion of, among others, irregularities concerning reported cardiac effects, and it would be a full decade and many cardiac deaths later that a black box warning was required for increased risk of cardiac events in men using Lupron.)  The government’s lawsuit focused only on Lupron’s inflated wholesale price, its fraudulent marketing schemes, and the kickbacks and bribes utilized by the company to ‘enhance’ Lupron sales.

Women in the past often reported that their doctors were shoving Lupron down their throats.  (Years later it would become known many physicians were making a nice profit per Lupron injection – i.e., see the company’s internal, confidential memo regarding Lupron’s money-making scheme in the field of urology).   During the era and context of women ubiquitously complaining of being pressured to take Lupron, these women did not want or seek or request Lupron.  Today it really scares me that the transgender youth want, seek, ‘need’, request, and look forward to receiving, and will fight to receive, Lupron.

Trying to Prevent Harm & Human Experimentation:

“I believe that a moratorium on and an investigation of the use of Lupron needs to be instituted immediately” were words I wrote in a 1997 testimony to the MA. Joint Committee on Health Care.  As the years and decades tick by without action, and the victims accumulate exponentially, I wonder how many tens of thousands (likely millions) would have been spared in these intervening 22 years had action been taken in 1997.

What will happen to these kids has bothered me for a long time.  In the late ‘90s, as an RN, I first encountered Lupron’s use as a “transgender adjunct” (and I refused to administer the injection), and this was the “one personal clinical observation” referenced in my ‘Incomplete A to Z list of off-label indications’.  More recently I briefly addressed some of the risks of Lupron ‘treatment’ for gender dysphoria in a series of articles I wrote (for heart wrenching excerpts from both mothers of and the now-grown children prescribed Lupron for precocious puberty, see here.)   So now knowing there is such a capable and dedicated force like the Kelsey Coalition gives me great hope for gaining recognition to the problems with injecting the “hazardous drug” Lupron/GnRHas into these kids.

I spent considerable time exploring your ‘First, Do No Harm” campaign’s link and associated pages, and you have hit the nail right on the head – it is indeed ALL medical providers that need to know the risks of Lupron.  I fully understand your campaign is focused on the transgender issue (and the risks of other drugs and the surgeries), and not focused on Lupron, but I believe these alerts will permeate thinking in the medical community as to the global negative effects of Lupron associated with all indications of use.

So I am thrilled and extremely impressed with your campaign’s organization and presentation.   Your ability to bring everything together so expertly is to be admired, and I think your campaign holds great promise.  I am really very appreciative of the Kelsey Coalition and its passion, commitment, and potential.  And I have good feelings that your efforts will be productive.  I’ll help in any way I can – and wish you much success.

Lynne Millican, RN, BSN, paralegal – disabled post-lupron

Founder, Lupron Victims Hub

https://www.lupronvictimshub.com/index.html

contact@lupronvictimshub.com

Boston, 11-11-19

Pdf_icon.png

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Tag Cloud

%d bloggers like this: