Hidden Clinical Trial Data about Lupron

For twenty-five years Lynne Millican has been promoting awareness of, and trying to prompt investigations into, the serious problems associated with the drug Lupron.

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In 1989, I received a prescription for the drug Lupron from a world-renowned Boston hospital for treatment of endometriosis and infertility.  Given the prestige of the institution, and the trust I had in my physician, when I was told that Lupron had been used safely throughout the world, I had no reason to doubt what I heard.

Soon after I began taking the drug, I experienced troubling symptoms, including hot flashes, insomnia, bone pain, GI problems, and headaches, amongst others. I began to question my treatment, and started scouring medical libraries and FDA documents for information to explain the adverse effects I was experiencing.

After years of research, I had good reason to believe that the use of Lupron for endometriosis was based on fraudulent clinical trial data. In 1995, I identified “manipulated figures” in a study by a leading Lupron investigator, who was later found to have “fabricated and falsified data” in four other Lupron studies.

During the past twenty-five years, I have written numerous letters to the FDA, testified before Congress, petitioned consumer protection groups, and hounded the media in a perpetual attempt to elicit awareness about, and investigation, of Lupron. While there has been some media attention regarding the risks of Lupron, no agency has acknowledged or addressed Lupron’s questionable clinical trial data, the accumulating iatrogenic injuries among those who have used Lupron, or the marginalization of Lupron victims. The emails to my website, Lupron Victims Hub, from victims needing help are profoundly disturbing and heart-wrenching; so many young and middle-aged lives (and families) devastated. Since 2009, thousands of people have been voicing serious complaints and disabling conditions on and/or after Lupron, and have likewise petitioned Congress for an investigation, to no avail.

In turning to the courts for justice and relief, the first Lupron victim/plaintiff to make it to trial (Karin Klein v. TAP/Abbott, 2011) encountered a bewildering array of perjury by the defendants’ medical expert and simultaneous silencing and prevention of the plaintiff’s medical expert to introduce facts. TAP/Abbott’s expert medical witness stated, under oath, that it was “biologically impossible for Lupron to affect the thyroid gland,” despite ample published evidence to the contrary. Having been given inaccurate information, the jury ruled against disabled plaintiff, a seventeen-year-old who developed (amongst other problems) a thyroid disorder post-Lupron. The plaintiff’s appeal to Ninth Circuit and US Supreme Court fell on deaf ears, undoubtedly deterring future Lupron litigation.

During the trial, Klein’s medical expert witness, world-renowned endometriosis surgeon Dr. David Redwine, had access to the thousands of pages of TAP/Abbott’s raw data from the Lupron endometriosis clinical trials. Dr. Redwine found that “62.5% of patients had not regained baseline estrogen levels by one year after stopping Lupron” identifying“definitive evidence of long-term damage to ovarian function.” Despite this damaging data from the clinical trials, Lupron’s manufacturer asserts on its label that the Lupron-induced low estrogen is “fully reversible upon discontinuation of therapy”.  The relevant raw data is now under a federal court seal.

In October 2011 Dr. Redwine provided the FDA with a 300-page Lupron Review alerting them to the hidden data and fraudulent outcomes that were not disclosed to the FDA (or consumers) during (or since) Lupron’s 1990 approval for pain management in endometriosis. The FDA’s 2013 response, which concluded that no regulatory action was needed, failed to even mention the hidden data and fraudulent outcomes.

Recently I have written several motions on behalf of another Lupron victim who is representing herself in court because her attorney retired and she has been unable to find proper legal counsel. These motions ask the court to unseal the endometriosis clinical trial data (originally owned by TAP/Abbott and now owned by AbbVie). The judge has taken these motions under advisement. The overt attempt by TAP/Abbott/AbbVie to keep its clinical trial data secret (and under court seal) suggests that the company has something to hide.

It is unconscionable and unacceptable, that any disabled Lupron victim such as myself would have to invest twenty-five years to make the “guardians of public safety”—the FDA, legislators, Congress, the courts, and consumer protection groups—do their job. When the FDA refuses to investigate evidence of fraudulent data, when legislators and Congress fail to act, where does one go, and when the Supreme Court declines to address perjury and the denial of a right to a fair trial, what can one do?

There should be an army of legal and medical experts exploring and exposing the nightmare that is Lupron. When each new Lupron victim contacts me for help, what should I tell them?

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Lynne Millican was a career admission unit, psychiatric nurse until physically disabled by Lupron. Presently, she serves as a resource for, and (as able) advocates on behalf of, Lupron victims through her website.

One comment

  1. Jacqueline · · Reply

    Have you any idea what is happening to the misinformed and emotionally compromised in a setting where their entire system, vs. the reproductive system exclusively, can be hijacked so as to chemically amplify an inert human drive, whilst halting the normal fight or flight response and incidentally disrupting numerous physiological processes essential for homeostasis? Have a closer look at the sheer rage of lasting side effects women report via the Lupron Victims Hub. I suggest manipulated data provided not only the basis for clinical trials that informed the FDA regarding Lupron in the treatment for endometriosis, but the very foundation for the self-regulated global IVF Industry.
    Considering the profound adverse effects GnRH agonists, like Lupron and its chemical alternatives Buserelin (Suprefact, Suprecor), Goserelin (Zoladex), Histrelin (Vantas, Supprelin), Nafarelin (Synarel), and Triptorelin (Trelstar, Decapeptyl) have on cognitive functioning alone (including memory, judgment and rational decision-making), I not only question initial shortfalls in informed consent, but also the notion of capacity to give consent following the potent chemical cocktails woman take during their first cycle. In this context, I suggest the legal contracts women enter regarding the extensive and expensive lists of “optional” procedures experimentally applied to their embryos or actual numbers transferred are worthless. I further assert, apart from generating serious long-term imbalances within the endocrine- and nervous systems, fertility drugs are highly addictive!
    In a situation where industry casually bypasses the notion of “minimum effective dose”, the borders between research and safe, effective treatment remain undisclosed and undefined, ovarian hyperstimulation syndrome and multiple births remain anticipated outcomes, and it is stipulated that in order for strong adverse reactions “to be worth it, you must continue with further cycles”, I urge anyone considering this predictably unpredictable procedure, to insist on a clear explanation as to how this “induced menopause” they undergo along with any potential “unexpected” effects can be reversed, before taking any drug by a name ending with -relin. In the short-term, this information may facilitate a speedy cost effective exit for those who find IVF is not for them; in the long-term it may salvage their quality of life.
    The Lupron Victims Hub was the only source of relevant information as to what was happening to me when I experienced a long list of lasting debilitating side effects that simply did not exist, either within fertility publications or the conscious awareness of my experts, following my first and only IVF attempt. Bioethicists, you have a duty of care to the public! I challenge you to explain the tremendous variety of lasting adverse effects woman persistently report, and publish any GnRH-agonist related concerns you may identify in media that is accessible by IVF consumers. Looking closely at the hypothalamus, the physical connection between the endocrine- and nervous systems, may provide initial insight. In the absence of any published data, supporting claims of lasting cognitive and physical impairments, affected patients are at risk of being misdiagnosed with an array of psychological disorders stemming from their “inability to emotionally cope with infertility”.

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