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.

24 comments

  1. Alissa · · Reply

    This is awful! I was on this poison 12 straight months because like u I trusted my Dr… Had I looked into it 3 years ago I would have never taken these shots.
    It’s disgraceful that this information has been kept sealed & caused so many more women to use it resulting in life altering damage.
    I’m now have thyroid problems, bone loss, constant injection site pain, hip pain, back pain, high BP not to mention all the hot flashes, mood swings etc etc.
    😥

    1. Your doctor likely does not even know this, it has been well hidden

  2. To @Dolphin, for three years I was on special diets. Organic eating, paleo, gluten free, vegan at one time. Countless amounts of money went into test diets and I did not see a result of pain relief. If I’d recall, I was doubling up on my pain medication. I worked out 6 days a week 1 hour a day. Stayed away from processed foods, added/refined sugars for 3 freaking years!! The pain never lifted. This was before my diagnoses mind you, but still. It irritates me when people say that eating healthy is the cure or it will fix your pain. It may have worked for some, including yourself and that’s great. It’s such a blessing to find the answers to our own pain management. Please though, keep in mind that this dieting thing is not for everyone. It WILL NOT fix every one. You may feel refreshed but it is nothing more than a “possible treatment”

    1. dolphin · ·

      Clix, I hope that you find what helps you. Diet played a HUGE part of my recovery. You should know that even exercise can be detrimental to the gut if you have leaky gut. You might check out heavy metal toxicity for the center component for your pain. I have that, also, and am in the process of chelating it out. Horrible dental amalgams!

      At Nancynurse—thank you for your helpful comment. As I said, I’ve been out of the loop for endometriosis causes and cures. It doesn’t surprise me, however, that they now say it is not the same as menstrual blood. Doofuses used to say that Endo was caused by women delaying childbearing — it was targeted at career women who wanted to get their careers started before beginning a family. So I would love to do some more research…do you have any websites that I can view that are up-do-date on Endo?

  3. dolphin · · Reply

    “Endometriosis is not autoimmune for clarification
    does not fit the definition” —

    This is news to me — I haven’t followed it for awhile, but the last that I heard it was being classified as autoimmune because of the menstrual blood attaching itself to the inner body due to some malfunction. They were thinking it was autoimmune because a lot of women have retrograde menstrual flow, but only a select few have it attach to the body….hence the attack on the body = autoimmune disorder.

    Knock wood, but I have not had any symptoms since beginning a gluten-free diet.

    Just my view, your mileage may vary.

    1. endo does not come from the uterus, that is old myth. the tissues are not the same, endo has fewer hormone receptors and there is no evidence of initial attachment that occurs when you transfer tissue from one place to another

  4. Barbara Bittinger · · Reply

    First of all, thank u lynne.God bless u for staying on top of this,it will pay off.i too had 5 lupron shots . My dr. Lied to me and manipulated me.id show up for appoint sobbing uncontrollably,severely depressed.i had such debilitating bone and muscle pain I could hardly walk (stiffness was debilt. Too).I got copies of office notes and was blown away.he documented how well I was doing on lupron with minimal problems.was he covering his ass or was he getting a kickback for giving it to me no matter what problems I was having?

  5. Brittany · · Reply

    I have been on depot lupron monthly injections for 7 years straight. That’s right 7 years. I am literally a human experiment.

    1. that is malpractice

  6. Renee chadwick melvin · · Reply

    Thank you for sharing your fight. I have not been on lupron yet in fighting the doctors who want to put me on it. I too have Endo, IC among a few more auto immune issues. And have researched this for years. It saddens me that some doctors go straight for something familiar instead reading the data.ive had 7 surgeries and need another as its been years. I’ve Tried so much. But my new dr wants me on lupron. I’ve listened and researched as the last dr mentioned it and I argued with him and never returned. But I asked her instead to look at my op reports and see if excising is on the table??? Take care and thank you
    Renee chadwick-melvin

    1. Just remember that you are the one who is going to have to live with whatever health decisions you make. And you have probably already realized how the world will abandon you if you become really sick.

      And I bet the doctor never mentioned diet to you as a way to combat autoimmune disease? Basically, gluten, soy, dairy, and corn are damaging to the immune system and you should not eat them. Eliminate all chemicals from your home, your diet, your life. Organic food only in non-processed form.

      Best of luck
      Robyn

    2. Endometriosis is not autoimmune for clarification
      does not fit the definition

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