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.


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?


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.


  1. Shawanda Davis · · Reply

    I was on Lupron for a year. It has totally messed me up. I have constant headaches, nausea, heart palpitations, joint pain, hot flashes, memory loss, nerve pain and I could go on. I do not know what to do. I can not work and I have a daughter to take care of. It has ruined my life..

  2. Tami D. · · Reply

    I am just another victim of this pidgin and wanted to add that it took me five years to figure out what was happening to my body. Since my first injection, I had dizziness but like others, wad not warned of adverse effects and went to my PCP who sent me for MRI which revealed “enlarged cervical lymph nodes”. Five years and many biopsies later after complaining of bone/joint pain, night sweats, memory loss, osteoarthritis in my neck and hip, and profound fatigue the doctor’s were stumped! Even A PET scan at Mayo revealed significant swelling in my airways and hyperplasia in throat! I’ve been out on disability for almost a year now, lost a terrific career working from home and traveling the country, and am about ready to go into isolation and leave my family for fear that I will eventually end this suffering.

    No one listens, no one cares until it happens to them! This CAN happen to you, your mom, your sister, your best friend…get my point?!

    Spread the word and share this article with all news and social media you can!

    Forever Changed!

  3. Jen Colville · · Reply

    I actually looked and joined lupron victims in 2006

    I will have to copy and paste my posts in 2006 to the lupron adverse side effects yahoo page. I found it in archives and read last year. It was so much worst than I remembered

    I don’t know how or why my husband stayed with me post lupron. Especially the first 2-3 years post. I wasn’t myself. I actually found out he cheated on me in 2003 when doing back to deployments than. He missed me. He was deployed so much. We didn’t spend our first anniversary together until the 3rd. He came home so different after that deployment and became self destructive and almost left him. He didn’t tell me he cheated until Jan 1,2010. He went away from training for 6 weeks so I had a lot of time to think about it. I thought about it for a few weeks. Week 1 I went to a therapist. I just had our 2nd miscarriage Dec 2009 and d&c Dec 31,2008. So the timing sucked. That’s what was the hardest for me. That changed me. I became jealous and bitter towards friends and even my sister getting of before me, without trying. A few people had 2 kids in the time I finally had my 2nd. I even had 4 laps during that time and used clomid. I used 9 rounds of clomid 50-150 mgs to end up with miscarriages so when he told me I saw a therapist . I told her how much he helped me during the beginning days of the lupron than following that with the bone tumor. He ended up having to go grocery shopping after his weekly haircuts. He was amazing with our daughter than too. In a way when he came home after cheating he self destructed and played an online video game all day and night for about 1.5 years. I almost left him but than he found out going to Iraq so he slowed down than stopped and spent more time with our daughter and myself than I did the lupron injection June 9 2006. He totally stepped up. He stepped up with the bone tumor too. He was so helpful when I had the d&c although he deployed 10 days afterwards. Than be told me the next year. I realized and therapist helped me but I came to it on my own. It’s like he was saying he was sorry. He felt so bad and so guilty. He spoke to therapist and chaplain and they said don’t tell me. They say that by the way. Cuz there is no way taking it back or the pain away. It’s like he was trying to make it up to me.

    I really needed him and I needed his support after lupron and for all these years later. He still goes grocery shopping for me. He takes the girls because he knows I can’t and I need that rest. Both our daughters are special needs and autism spectrum. . My body is getting worst. I am probably going to need a wheelchair soon. I’ve been fighting it for so long. I usually just push myself and have for years. I’m too tired and hurt to push myself any longer.

  4. I just want to add besides the physical damage it did to me the psychological damage was just as bad if not worse. My whole thought process was changed. My memory to this day is damaged. I had the series of 6 shots back in 1992. My whole personality changed. I had no idea what was happening to me. I ended up in a psyco ward. I lost everything and everyone because they thought I went crazy. No one to this day believes Lupron was part of the problem. I am intelligent and also have regained the psychological aspects of my mind except I still have memory problems. It took me until 2011 to feel like myself in my mind again. That’s my mind as for my body I have so much pain, just go down the list that others have reported I can check off quite a few. Too many. I would like to know if it has been reported that others that took lupron had severe psychological effects as mine. I need to show my ex-husband, family but mostly my 3 children, who are now adults that it happen to others. They need to know that other Mothers got sick. I did not harm them in any other way except for being sick in the hospital and not being able to take care of them when I was home. Never laid a finger on them but I could not hold a job and the father of my 3 tricked me into letting him take them until I felt better. We had a beautiful marriage and family life… Until Lupron. I am begging that if anyone is not ashamed to tell me & my kids how the psychological part tore apart your family please do. The only ones I will show it to is my Children. You may just heal the wounds we can’t find answers to. Please. My name is Michele Musko e-mail onel711@yahoo.com or just respond to this page and hope I will get it There is no shame in what has happened to us all. God Bless and stay as well as possible.

  5. Jen Colville · · Reply

    I did one injection of lupron in 2006. My life has forever changed. My severe side effects started right away. I have never been in so much pain. That was my 10. Severe/excruciating bone pain, pelvic/abdominal pain I had a seizure, fainted. I went to the ER 3 times the first 2 weeks. My PCM was extremely worried. My BP was sky high. He was really helpful. I think he was so shocked what this drug, no poison did to me. My daughter was 1. I lived over 9 hours from family but my mother in law had to move in with me for a month. I couldn’t even hold my child. I was completely bedridden. I couldn’t walk. I also had a bone tumor that became extremely aggressive in my leg. Most likely from the lupron. I also had tachycardia. I started TTC about a year afterwards but took 4.5 years to get pg after 2 miscarriages. I was hyperthroid I have arthritis/bone/nerve and muscle damage. My new pain management dr said he has seen several women years after a medical history of lupron. My Gyn didn’t fight me that lupron did this. I didn’t just have a little bit of bone pain, it was so severe. I also suffer from severe migraines since. I get so sick I vomit and faint. I have been told I had severe adverse reactions, but very bizarre and a very small percentage responds that way. I did join a lupron support group on Yahoo. I re read them last year. I actually have been downplaying my pain. I have memory issues. When I re read my posts you can see how much pain I was in. I missed seeing my daughter’s first steps. A year ago I found petition website for lupron and learned my reactions weren’t that bizarre and that this is never going to get better. I have been getting worst over the years. I am detoriating. I have kidney and bladder problems too. We should have a diagnosis. We should be known that this drug has disabled us. I haven’t been able to work. Heck, I can’t even go grocery shopping. I want them to stop giving this poison. It’s not a cure. It actually made my pelvic pain worst, very heavy bleeding. My dr before during hysterectomy wanted me to do another round, we move a lot. So different Gyn. I was told I need to do 3 rounds. I just broke down in tears. I said it would kill me. I wanted to die. My husband and daughter were the reasons I fought to live. I would kill myself if they made me do another round. I had no emotion so they could see I was serious and it wasn’t happening. My husband has been so leery with me if I mention the word injection. I don’t think I will ever heal. It hurts me when I see women prescribed this. I tell anyone not to. I’ve heard oh, well you have all these medical problems, I’m not like you. I didn’t have these problems before lupron.

    1. Jacqueline · ·

      Jen, so sorry to hear you suffered for 10 years after only one lupron injection. Still you could see your way clear to spell out some of your side effects here. No doubt many readers will benefit from this information, which is very difficult, if not impossible, to come by elsewhere (except the Lupron Victims Hub) – most certainly not within the clinical setting where this drug is still offered.

      Among the many serious, life-altering adverse events listed, you pointed to what I believe is key to at least partially explaining as to how it was even possible for a drug, causing such an array of long-term problems for their unsuspecting consumers to remain in circulation for decades: It has profound and lasting effects on cognitive functioning overall. Specifically on memory, including the ability to retain and integrate new information, to learn from mistakes or to adjust to and let go of misguided believes, even if they are emotionally significant; (as in the case of IVF where women publically question the safety of their treatments, spelling out their side effects to each other, and yet continue with further cycles, even though they must realize that the long awaited “success” would require them to grow their child in a sick body).

      With injured parties prevented from seeking due compensation, initial trial data under legal lock and key, it yet remains to be seen for how long AbbVie (and other GnRH-a manufacturers) will be able to hang onto their market, whilst consumers benefit from modern information technologies, including support forums, which help them not only to record and later recall events as they really occurred, but also let others learn from their mistakes, as this information becomes available to the world. No reasonable person would take this type of drug, if they were adequately informed of its short- and long-term effects, no matter what the “potential” benefits.

      Lynne on her Lupron Victims Hub summarized that practicing experts have been aware of GnRH-a’s adverse effects on memory for over two decades as follows:

      “A TAP advertisement in a fertility journal gives a glimpse into the sly canvas upon which the industry paints its picture: This TAP Lupron ad read:

      “Remote Control: Your patient with endometriosis doesn’t have to remember her daily therapy – Lupron Depot 3.75 mg remembers it for her. … She only needs to remember six monthly visits.” (Ad, 1992).

      Nowhere does the consumer learn that memory loss has been known to be “a commonly observed” side effect to Lupron, or that patient noncompliance with daily Lupron could likely have been related to a memory disorder (listed as a known adverse event to Lupron), or that clinical trials conducted for Lupron depot approval utilized methodologically flawed study design that was conducive to subjects forgetting adverse events (surveyed every 30 days).

      Ad: TAP Lupron Depot Advertisement. i.e.; September 1992. Remote Control. Fertility and Sterility, 58(3).”

    2. Jen Colville · ·

      Yes ,

      I can see the memory and shot because daily lupron would forget. I don’t understand why isn’t a choice? Why can’t it be like birth control? Is with endometriosis don’t forget to take the pill and take same time because we don’t want to spot/cramp . We are really good about that.

      Also why isn’t there genetics of lupron? How are they getting away with that? Maybe that’s how we break the court ordered seal is because it seems illegal to have a brand name patent that long or is that why they do the TAP to Abbott to Albie (or the new company). Because that is a monopoly and there is a certain time frame that can have a brand name without genetics being able to replicate. Just like you see with Phizer, I hate this manufacturer too.

      But yes , I have memory problems and my personality changed. I became very needy and dependent on people but I lost my patience and became just mean (years later). Say words I don’t mean. I type this too. Usually it’s the opposite word. Sometimes when people talk to me or write or type something. I do t know what they are talking about? I have major memory problems. I always knew it affects our thyroid but also pituitary gland (such an important gland. I think this is why we see such varying and several different bodily symptoms affected). But also the hypothalamus gland. Lupron works like a time released drug. If take ADHD meds or morphine like MS contin, slow acting or ADHD meds like focalin xr is time released and taken one day or concerta is Ritalin but time released taken daily. Some people can’t handle time released especially if fast ultra sensitive metabolizers. I can’t even take fast acting allergy med OTC. I took 1 tablet and had to call nurse online figuring out what is wrong. It was so bad I was hullo imaging, seeing double, palpitations, fainting and passing out. (This is something that happened post lupron it’s POTS, postural osthatic tachycardia syndrome. I never had migraines until lupron. It was awful. (because I do because of lupron. Thank god I have an understanding pain management dr. I was shocked he admitted to me he has seen several patients, especially women with such horrible & irreversible side effects with a history of lupron.

      I found out they give lupron to breast/ovary/reproductive cancers to women survivors. Their symptoms for lupron on cancer sites actually say bone loss and osteoporosis. Why doesn’t it for endometriosis? Because women teens, 20s,30s and 40s would say no. They are saying depo shot is causing it too. The long term hormone anything injections are so bad for women. I am sure it would cause issues with not only what we already know but what about heart disease. I have a peripheral circulatory issue now as well as osteopenia. But I think that much estrogen and lupron floods us with estrogen at first that’s how they are able to shutdown our ovaries and pituitary and hypothalamus and than is like oh, don’t need need to make any more estrogen, lh hormone, progesterone, nothing. I think that’s why we are seeing ovary function shutdown as well as progesterone issues such as short luteral phase of progesterone deficiency. Speaking of which mineral and vit deficiency. It needs to be recalled and banned than we sue. So what if go ou of business. We know how and why they put it under court order. Maybe we can discuss or see if a dr can conduct a study. But I feel so bad for whoever uses the lupron.
      I actually read a report saying that metadata is changed fraudulently with anti depressants (psych meds). And article said they believe that most of the metadata for different meds are fraudulent. This is for birth control, heart meds, thyroid meds, antibiotics, pain meds, nerve meds, seizure meds and so on. You get the idea and the FDA doesn’t work the way that we thought it did. I don’t think manufacturers should even be allowed to know who , what company , nothing because can’t even bribe the dr’s and researchers to change the metadata. The drug is given a number and not told anything except like they tell us if it’s received than accepted, than processing refund and when refunded. That’s how they should do it with the drug manufactureres because we are getting drugs released that shouldn’t. Change the rules for generics and brand names. That was something Obama wanted to do. Was change the years for brand name to be longer than it is. This is going to cause so many problems. Look up Scott Reubenstejn and Phizer. See that I’m telling the truth.

  6. I so wish someone like Erin Brockovich would take an interest

  7. good for you/her. The data deserves to be seen even though the FDA chose not to act. I have seen the work Dr Redwine did as I proof read it. Very frustrating to know that the drug is significantly more damaging that the company admits and that information cannot be shared with physicians or patients. Now insurance companies are starting to require patients go thru two courses of lupron before even approving a surgery. Talk about drug company targeted marketing

  8. dolphin · · Reply

    I’ve unknowingly been dealing with Synarel side effects. I had taken it in 1991 for Endometriosis, along with Seldane. I suffered numbness down my left arm, chest pressure like an elephant was sitting on it, chest pain, an inability to speak at the time of the episode. I know that I had a heart attack. Predictably, my physician denied that Synarel or Seldane had anything to do with what happened. He referred me to a neurologist, who said it was a complicated migraine. End of story for them. Problem solved.

    Yeah, not so fast.

    I have had monthly migraines a year after having dental amalgams placed in 1994. I suffered with declining health and changed personality until 2007, when I found a website devoted to heavy metal poisoning. I thought I had found my answer. Indeed, chelation therapy has helped, along with going gluten free on the GAPS diet, but what I was hoping for was an end to my migraines. I mean, that was my ultimate goal to be pain free after twenty years of suffering.

    But I have had three bad migraines in a row. With the last one, I had the exact same symptoms that I had the night of the heart attack in 1991!!

    I mean everything — chest pain and pressure, fever and chills, back ache, skin feeling so heavy that it will fall off, muscle aches, nausea to the point of throwing up and a migraine. I lose five pounds every single month with these migraines. Sometimes I’ve even lost ten pounds. Scary. I gain it all back and then this circus starts again.

    I knew this had to be Synarel — that it had permanently altered my pituitary function and that it wasn’t just heavy metal poisoning. That’s when I found Lynne Millican’s website and the horrible destruction these drugs have caused. And nobody seems to give a rip. That’s what is so troubling. Sociopaths running our healthcare system….

  9. Shannon Rosser · · Reply

    This drug ruined my life…and mostly because as my health crumbled and the pain became hard to bear, I was repeatedly told by doctor after doctor that these were not known side effects. Well they know them now, but my life is a shell and I haven’t worked in years. The not being able to work was crushing – I LOVED my career. And no disability $$, either, since I couldn’t produce a diagnosis (not that I wanted disability – I wanted to work.). Years later, I am no longer hoping for anything much and get very depressed very often. I was fortunate compared to many victims as I had earned a lot for years and saved like crazy. But not every person was fortunate enough to have the opportunities I did. I would do anything to help get justice for all of us whose lives were ruined. Feel free to contact me.

  10. 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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