There’s a Los Angeles Endo Event taking place on March 25, 2018, at 2:00pm at the Clove Coffee Graden! If you’d like to attend the Tea & Talk with Everything Endo event, please email them for more information.
Our friends at the Endometriosis Family Support Group are at it again! On March 6, 2018, at 5:30pm (PST), they’ll be hosting a Webinar with Meghan Cleary, one of our local EndoSisters!
For more information, AND to register, email Megan.
And another week has gone by. This one flew! I’ve been so incredibly busy with work and personal life. Augh! And February draws to a close…
This weekend I’ll be celebrating an annual tradition with beautiful friends: Girl’s Day Weekend! A handful of girlfriends that I’ve known for nearly a decade (and then some) get together at least once a year to reconnect, hang out, giggle, and just chill.
As I packed my bags and headed out the door this morning, my lovely husband gave me a kiss and reminded me to take it easy, to not push myself too hard, to take rests and breaks as I need them. He’s been aware the past few weeks had been painful for me. And his gentle reminder to be gentle with myself warmed my heart.
It has inspired today’s very simple, yet very powerful, quote:
“Be good to yourself.”
― Lailah Gifty Akita, Think Great: Be Great!
Have a wonderful weekend. And if you need it, remember to take it easy on yourself.
Blogs I’ve updated this week:
Readers Choice: Can Men Get Endometriosis – added a 2018 study of a man who developed Endometriosis.
Support Group Meeting – our next meeting will be Saturday March 31st
Oh, it’s that time of week again! FRIDAY!
What a bumpy and painful week it’s been for me. But, on the plus side, today is my first pain-free day since last Friday. So YAY! Hopefully it lasts. I hope you, my dear Readers, are doing well.
Today’s quote dares you to get out and DO:
“Be fearless. Have the courage to take risks. Go where there are no guarantees. Get out of your comfort zone even if it means being uncomfortable. The road less traveled is sometimes fraught with barricades bumps and uncharted terrain. But it is on that road where your character is truly tested And have the courage to accept that you’re not perfect nothing is and no one is — and that’s OK.”
― Katie Couric
May you get out there and step outside your comfort zone, go nuts, have fun, and discover a bit of adventure and mischief. ❤
Genevieve felt the symptoms of Endometriosis since her first period. She was diagnosed when she was 21 years old, and is now 28. She shares her story with us today.
Genevieve’s Journey: I thought I was dying.
I was on a family holiday, lying in our camper trailer bed with my mum and my little brother. I was 12. I think my poor mum, who was a nurse, was at her wits end by sunrise, and had given up trying to diagnose me after an hour or so. The pain in my abdomen had me convulsing, crying and curled up into a ball clinging my legs to my chest for dear life while I rocked back and forth. I was given some Panadol, and while my mum and brother proceeded to sleep, I made the cold, windy walk up the hill to the campsite toilets over a dozen times throughout the night thinking, “This is it. I’m going to be one of those news articles, where a young girl dies a mysterious death in a caravan park”. I remember sitting in the showers in the middle of the night, on my thongs (so I didn’t get butt tinea from the shared bathroom) and just feeling like I should have been at a hospital. But I was so desperate not to cause a scene or be put on to a helicopter in front of the entire Robe Caravan Park.
Alas, I was not dying. I was ‘becoming a woman’. Well, I tell you what, my mum was extremely excited (and relieved) when I informed her of the milestone the next morning, but I, on the other hand, was mortified and equally terrified at the thought of this happening on the regular. If this was to be normal, I was pissed off that nobody warned me that ‘period cramps’ felt like hot lava and barbed wire having party in my uterus. Over the next six or so years, I missed a fair whack of school, wrapped up on the couch with hot water bottles and blankets, and a plethora of pain medication – much to the confusion of my parents who wondered how I could possibly be in that much pain. I skipped classes regularly to go and hide in the change rooms so that I could lie on the floor in the foetal position and try and survive the rest of the day.
For the next 10 years, I was assured that this pain was normal, and that all girls go through it. I was admitted to hospital twice with ‘suspected appendicitis’ when in actual fact, it was just a period. Lucky old me also didn’t have to wait a precise 28 days. Oh no. I was blessed to have 10, 65, 4 or 27 day cycles. They were never normal and they were never short. Because of this, teachers didn’t believe me when I would tell them what was going on – “you used that excuse the other week/day” they would say. I suspect (sorry mum) that my parents also thought I was just piking out of school most of the time.
At one stage in my life, I even had a boyfriend who laughed in my face when he saw me fall out of bed after rolling around in agony whilst howling with tears. That same night I was having difficulty seeing clearly because the pain was, literally, blinding. I could barely walk, yet I was told to drive myself to the hospital while he begrudgingly slept in the passenger seat, because “calling an ambulance is a bit dramatic, don’t you think? I will go, but for the record I think you’re overreacting”. So I did (this was also before I grew a backbone and some balls – not literally). Word to the wise ladies, if this is something you are facing in a relationship, kick them to the curb! Even typing this out makes me mad.
Now, before this story gets any darker, I will stop with the descriptions. I’m sure you get the picture. There were a lot of times where this wasn’t an issue and I got to live a normal life. I am in a far better position than so many other Endo Warriors. For that, I am beyond grateful and humbled.
However, pain that stops you from living your life and carrying on with normal day-to-day activities isn’t normal. Let me just repeat that:
IT’S. NOT. NORMAL. Don’t let anyone tell you that you are overreacting. Or that it’s a normal part of being a woman.
Unfortunately, “there is delay in diagnosis of between 7 and 10 years. This is due to girls and women normalizing symptoms as well as doctors normalizing symptoms when women do finally seek medical assistance. Early diagnosis and treatment reduce the long term impacts of Endometriosis and frequency of invasive treatments and fertility treatments. Raising awareness is the first step to reducing the delay in diagnosis across all age groups. Education about menstrual health, what is normal and what is not is vital in younger age groups to break the current cycle of delay in diagnosis and flow on affects for the next generation (Ballard, K. Lowtan, K. Wright, J. 2006 & Dessole, M. Benedetto Melis, G., Angioni, S., 2012)”
I hope that one day, more open and honest discussions about periods can happen, and help is offered to girls at a much younger age. This March is Endometriosis Awareness Month, and I plan to be involved in this in any way that I can. We need to raise awareness of this chronic illness, so young girls like me don’t wait 10 years to get help.
If you look at my more recent Endo situation, this is where I am at:
My current varying symptoms include extreme pelvic pain, severe back pain between my hips (which gets far worse if I eat any gluten or stay seated for long periods of time). I get shooting pain down my legs, experience hot flushes, night sweats, anxiety and extreme fatigue. Add on to this more than occasional bouts of IBS, sore breasts, headaches, irregular bleeding and emotional fluctuations that I can never keep up with. I have suffered with these symptoms for over 15 years and not just when I have my period (if only it were that simple!). I have had two laparoscopies, my first when I was 20 and the Gyno ‘found nothing’. Fast forward 7 years to my second surgery, where not only was there Endo, it was so severe that my surgery was extended from the expected 30 minutes to almost two hours, where they burnt off lesions throughout the left side of my outer uterus lining, and cut out adhesions on the right side which had fused my bowel to my abdominal wall. I still remember seeing the doctors face –I wish I was a mind reader- I could have sworn he was surprised and almost felt ashamed that he had initially said to me: “there’s probably nothing wrong with you if nothing was found in your first laparoscopy”. Oh how wrong he was, and this was said to me by an Endometriosis specialist. In the almost two years since this surgery took place, my back pain, digestion troubles and fatigue have only increased. The one upside is I finally found a new and fantastic Gyno who has treated me and my Endo from every imaginable angle. I am now in a position where I am managing my pain with a combination of nerve-blocking medication, pain relieving suppositories (fun!), and being put on the FODMAP diet which eventually led to me finding out a huge trigger for my poor operated-on-bowel, was gluten.
So, aside from saying goodbye to three big loves of my life: pizza, pasta and bread, things could totally be worse, and I know right now I am doing ok, but tomorrow could be a totally different story. I have started my blog to start sharing my story, and help get word out there.
I am only one spokesperson for women with Endo, but I feel like I am not alone in saying most of the time, we just want to be understood and accepted, and our pain and suffering to be acknowledged appropriately. This March is Endometriosis Awareness Month, and I will be wearing yellow every day to show my support and involvement. 1 in 10 women have Endo- think about how many women you know. Chances are more than a few of them have been suffering in silence for a long time. I honestly believe that if we want things to change, for young girls to get diagnosed and cared for earlier, then it’s the responsibility of everyone, to recognise what Endo is, and what toll it takes on women all over the world. How will you show support for women with Endo this month or in the years ahead? What will you do differently?
There are so many resources and links with information online, but the other thing that can be really informative- is to ask us, the women with Endo the questions. We live with it every day, and when someone shows interest or concern, that’s one more person who is on their way to understanding and accepting and helping us see some change.
I want to send a special Thank You out to her for being brave enough to share her personal story, struggle, and victories with us today. I am so grateful that you have found a Gyno who takes your pain seriously and is attacking it head-on! Your words of encouragement, your positive attitude, and your passion – it’s contagious! You are a beautiful, brave, and strong woman. Thank you!!!
And if YOU would like to share your story, please contact me. The best part about this disease is the strong network of love and support from our fellow EndoSisters, and our friends and family, too.
Welcome to another Friday. We made it through yet another week!
Here I sit today laying in bed, wrapped around my heating pad, taking a sick day from work. My pain has been sneaking up on me these past few days: had a lovely incident EndoBelly earlier this week, had an incredible acupuncture session, and spent yesterday with my microwavable heating pad all day while I was at work. So today I’m laying in bed, with Tramadol coursing through my system, as I am patiently waiting for it to kick in and take away my pain.
It’s on a day like today where I’m reminded that self care is not selfish. I don’t like taking days off of work. I have very few and very precious sick days available to me to last throughout the year. That being said, I also acknowledge that my comfort and my health and my mental well-being are incredibly important and sometimes I need to focus purely on me. Had I gone to work today, I can almost guarantee you that I would have made it to lunch and then begged off to stay home for the rest of the day. I also likely would have regretted going in in the morning when I could have stayed at home laying in bed embracing my heating pad and my agony.
I know that endometriosis is not curable. I know that pain medications are a Band-Aid. I know that birth control pills, Lupron Depo, Danzanol, Letrozole, and any sort of medication marketed toward reducing the symptoms of endometriosis are all purely Band-Aids with awful side effects. I know that excision surgery is considered the “gold standard” to treat endometriosis. I also fully understand that it’s not a guarantee that my pain will not return. Acknowledging that the treatments are insufficient at times, and acknowledging that this filthy disease may return whenever it wishes, doesn’t make it any easier to deal with.
There are good days. There are bad days. Today is a bad day.
I’ve been lucky enough to have two excision surgeries by a surgeon I believe to be incredibly skilled and knowledgeable and passionate about treating our illness. There are times like today where my pain is so bad that all I want to do is feel sorry for myself, and I do for a little bit. But, something deep down inside reminds me that I can get through this. I may not be able to get through this well today, but I can get through this and I will resume the good days hopefully very soon.
You have to find a light at the end of the tunnel somewhere even if you can’t see it yet, it’s there… Somewhere.
One of my readers, Erin, emailed me asking if I could look into taking Melatonin for Endometriosis pain and symptoms. She had heard that it may help reduce the symptoms, pain, and maybe even the lesions themselves.
So, on goes my Research Cap and it begins!
Melatonin is a natural hormone produced by the body as the light fades. Many people take Melatonin to help them fall asleep and stay asleep. It’s been coming out in studies over the past decade that Melatonin may play a role in helping reduce Endometriosis lesions and pain.
In 2008, a study was published about 25 rats that were surgically implanted with Endometriosis. Interesting enough, it found that the rats that were treated with Melatonin were found to have fewer and smaller Endometriosis lesions than rats that received nothing.
In 2010, another rat study took place, this time comparing rats who were given Melatonin to rats who were given Letrozole. Thirty rats were induced with Endometriosis, given Estrogen for 2 weeks, then surgically confirmed to have Endometriosis lesions present. Some received Letrozole for 2 weeks. Others received Melatonin for 2 weeks. They were all surgically opened up and their Endometriosis lesions were recorded and measured. The rats received another 2 weeks of Estrogen, then were finally studied. It found that the rats who received Melatonin had fewer and smaller lesions than the rats that were given Letrozole.
In 2012, Melatonin was referenced in a study about different types of pharmacological treatments of Endometriosis. It stated that past studied have shown that daily Melatonin usage had reduced the volume and size of lesions and reduced oxidative stress markers. As far a dosing goes, rats were given 10mg a day for 18-28 days. It stresses that the doses had not yet been tested on humans.
A Brazilian study published in 2013 found stated that Melatonin was thought to help Endometriosis because it’s an analgesic, antioxidant, and anti-inflammatory. It studied 40 women over an 8-week period. Some of them were given a placebo, and the others were given 10mg of Melatonin each day for 8 weeks. For those who took the Melatonin, 40% of them had reduced daily pain and 38% of them had reduced painful periods. They also had an improved quality of sleep.
In March 2015, a study was published discusses various doses of Melatonin given to rats that had been implanted with Endometriosis. Unfortunately, the abstract did not divulge the doses given to each rat and the results. It did; however, state that Melatonin treatment did result in the regression of lesions in the rats.
I know I’m excited to read about the possible benefits of Melatonin when it comes to Endometriosis. BUT, there’s always a “but”…
The US Department of Health and Human Services states short-term Melatonin use appears safe; however, little is known about the safety of long-term Melatonin usage since studies of long-term effects have not been conducted. Also, some people have complained of side effects while taking Melatonin: dizziness, drowsiness, headache, irritability, nausea, and stomach cramps. Many users have also complained of grogginess the next day.
Then there’s the question of dosing. What is the appropriate dose of Melatonin? A 2001 study identified the proper dose of Melatonin to help people sleep is 0.3mg per day, taken just before bed. Sleep.org stated a dose between 0.2mg and 5mg taken an hour before bed would be sufficient. For people who have sleep-wake cycle problems, they’ve taken 2-12mg of Melatonin for 4 weeks. The study of Endometriosis in women was a 10mg supplement for 8 weeks.
There are also indications that Melatonin may worsen depression, cause high blood pressure (or negate blood pressure medications), worsen bleeding in people with bleeding disorders, may interfere with immunosuppressive therapy (for organ donor patients, etc.), and may increase blood sugar levels of diabetics.
Don’t forget about the “don’t take this medication with this medication” category. Since Melatonin may be a sedative for many people, avoid taking Melatonin if you take other medications that may cause drowsiness. Some examples would include Klonopin, Ativan, Donnatal, and Ambien.
There is some concern out that that taking Melatonin may cause hormonal issues. Since Melatonin is technically a hormone created by the body, supplementing it may cause imbalances or
As always, please talk to your physician before starting any type of new regimen, whether it be pharmaceutical, supplements, diet, or lifestyle changes. I know I’ll be talking to my physician. And always understand that little is regulated in the supplements market. Do you own research and act wisely.
Do you take Melatonin for your Endometriosis? Have you noticed a difference? Please let us know by leaving a comment below!
(Updated March 27, 2019)
Archives of Gynecology and Obstetrics (March 2015, Abstract) The Effects of Different Doses of Melatonin Treatment on Endometrial Implants in an Oopherectomized Rat Endometriosis Model
Dr. Tori Hudson – (May 2014, Blog) The Effect of Melatonin in the Treatment of Endometriosis
Empowered Sustenance – (June 2014, Blog) Melatonin Isn’t a Sleeping Pill: 3 Reasons to Avoid Melatonin
Fertility & Sterility (April 2008, Article) Regression of Endometrial Explants in a Rat Model of Endometriosis Treated with Melatonin
Fertility & Sterility (April 2010, Article) The Effects of Letrozole and Melatonin on Surgically Induced Endometriosis in a Rat Model: A Preliminary Study
Fertility & Sterility (Sept. 2012, Article) Pharmacologic Therapies in Endometriosis: A Systematic Review
Huffington Post (March 2016, Article) Read This if You Take Melatonin to Sleep at Night
National Center for Complementary and Integrative Health – Melatonin: In Depth
PAIN – (June 2013, Abstract) Efficacy of Melatonin in the Treatment of Endometriosis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial
WebMD – Melatonin
~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa
Always a sweet surprise to find out you’ve been nominated for a fun bloggy-award. And by my good friend and stalker, Marixsa, is the culprit for this one. She writes The Endo Zone, an incredible blog about her journey coping with Endometriosis and infertility, her life, and her adventures. And I love her to pieces. TO PIECES!!! Thanks Stalker! xoxoxo
So, what’s the Liebster award?
HERE’S THE RULES:
- Thank the blogger who nominated you and link to their post.
- Answer the 11 questions they asked you.
- Nominate 11 other bloggers, with your own set of questions.
- Tag your chosen 11 bloggers, and don’t forget to tell them as well!
1. Imagine that the blogosphere suddenly disappears—for whatever reason. What do you do? Well, seeing as I didn’t blog until 2014, I’m sure I’d survive. Before my blogging days, did I write much? Nope. When I was a kid, I used to write almost daily in my diary. I kept that habit up until I reached my 20s. Then…nothing. But now I have a passion and a drive to share…to reach…to blab. If the blogosphere disappeared (and assuming so did the ability to create a pseudo-blog), I’d probably reach out to magazines, newspapers, columns, etc. to continue to try to not clam up about Endometriosis. Social media would continue to be a forum, too, that I would use and abuse. Smoke signals. A message in a bottle. Graffiti. I’d go nuts…
2. What characteristic do you not possess at all? This was a fun one. Since I’m not well-versed in the large array of characteristics out there, I hit a webpage to help me out! I spent some time perusing the list, looking up words that were unfamiliar, and analyzing myself inside and out. I came up with milquetoast. Not only did I learn a new word that is hilarious to say, but it’s so very true. As a child and teenager, I was shy and quiet and watching from the shadows waiting for life to happen to me. As an adult, I could care less. I’m loud and boisterous and not afraid to go up and talk to strangers and strike up a conversation. I’ll eagerly step forward to pitch in and participate in whatever strikes my fancy. There are no more shadows to cling to. There’s no self-doubt that I won’t be accepted…I’m out and doing and enjoying. Except when it comes to dancing…I just don’t know what to do with my hands! And if you try to tell me I can’t do something, that simply fuels the fire and motivation to DO IT!
I’m not sure when the big switch occurred from my shy childhood to my confident adulthood. But I’m glad it did.
3. Why did the chicken cross the road? To marry me at Burning Man in 2011. 🙂 Awww, my dear sweet best friend Rosie and I out on our dusty adventures.
4. How do you face critical problems? Horribly. If I have a plan, I’m usually okay. But most critical problems are also an unsuspected crisis or something I don’t have any control over. And when I don’t have control, or I can’t plan, or there’s nothing I can do to solve the issue…I tend to freak out. First, my ears get hot…literally red hot, then I get loud and stompy and annoyed and suffer from tunnel vision. Then I obsess. Which only makes all the rest of it worse! BUT…if it’s a critical problem I can sit down, analyze, and formulate some sort of plan to begin to tackle it, it’s a much different scenario. I’m calm, collected, have my “steps” that I must first accomplish, and can start whittling away toward a solution.
5. One thing about yourself of which you are most proud? Embracing my diagnosis, fighting through the immediate depression of learning I have an incurable and painful disease, and pushing ahead to find and support others with this same condition. Due to that urge to fight back, I’ve found an incredible community and am helping others.
6. The happiest moment of your life? The day I reconnected with my family after nearly a decade of strained relations.
7. A word which you hate to use? Pejorative words used to describe a person’s sexual preference, socioeconomic status, race, etc. I hate to use them and I hate to hear them used by others. If you need an example, Wikipedia has a long list.
8. What is your dream job? I love my job as a paralegal. But if I lost my job and couldn’t find another in this field, I’d want to be a librarian in some tiny little town…just me and a bunch of books.
9. What villainous character do you most admire, and why? Cobra Commander. I don’t really know why, but he’s been my favorite bad guy since I was a little kid playing with my brothers’ GI Joe figurines. We used to watch the cartoon religiously. And I don’t think he’ll ever be topped.
10. Item on your bucket list that you would be MOST upset if you didn’t accomplish. Staying the night at the Titan Missile Museum in Arizona, eating pizza, playing war simulations, and bunking down in the crew quarters for the evening. It’s an expensive endeavor, but one day I’d love to.
11. If you could have lunch with any famous person, dead or alive, who would it be and what would you order? Oh man, this one was easy! I’d enjoy fluffernutter sandwiches with Elvis Presley.
The 11 bloggers I nominate are the first 11 blogs (in order) I started following on WordPress 🙂 :
- Holding My Childhood to Ransom
- Fanciful Wish
- Glory Girl
- Endometriosis – My Journey
- Fighting Endometriosis
- The Endo the World
- The Trials and Tribulations of my Search for True Health
- Invisible Pain Warriors
- Surviving Endometriosis
- Cuilverse: Shadow in the Mirror
- Shanna Beale
And the 11 questions I pose to these wonderful bloggers?
- What are some things that you wished people knew about you?
- What movie would be greatly improved if it was made into a musical?
- What is the weirdest thing you have seen in someone else’s home?
- If you were arrested with no explanation, what would your friends and family assume you had done?
- When people come to you for help, what do they usually want help with?
- What was the best book or series that you’ve ever read?
- What fad or trend do you hope comes back?
- What are some of the events in your life that made you who you are?
- What irrational fear do you have?
- What’s one thing you did that you really wish you could go back and undo?
- If you could convince everyone in the world to do one thing at the same time, what would that thing be?
Have fun!!!!! 🙂
Updated note (July 25, 2018): Orilissa (Elagolix) was approved by the FDA on July 23, 2018.
I don’t have TV, but I’ve had a lot of friends and loved ones excitedly tell me that they saw a commercial about Endometriosis recently! I think that’s awesome! A wonderful way to spread awareness to so many people!
Like one friend said, it took me 20 years for a diagnosis – maybe it wouldn’t have taken so long if I had seen a commercial similar to this one. If it can help just one woman begin to search for answers, it’s awesome.
So, I checked out their webpage, SpeakEndo.com and watched the recent TV ad. If you haven’t seen it, you can watch it here. In late August 2018, a new commercial was released, which you can watch here. I thought it was wonderful for encouraging women to be open and honest about their pain symptoms. Periods aren’t embarrassing – just tell your doctor so they can make sure everything is okay. They won’t know something is wrong if you don’t speak up! Embrace that personal power and self-advocacy!!
SpeakEndo also creates a community for women to share stories, bond, and learn together. It also provides resources on how to prepare for an appointment with a physician to discuss Endometriosis. And it gets better: for every person who signs up on SpeakEndo, a donation is made to the Endometriosis Foundation of America; although it doesn’t state what that donation amount is.
Then I did some digging. And please understand: this is an expression of my opinion. I developed it based on gut feelings and what little internet information I could find. Purely my opinion. Please feel free to do your own research, digging, and thinking:
AbbVie’s name hovered over the commercial toward the end after they released the webpage information. “Who’s Abbvie”, you ask? A pharmaceutical company. Not just any pharmaceutical company, but the one who manufactures and markets Lupron Depot, a GnRH agonist used aggressively by physicians to treat the symptoms of Endometriosis. I was on Lupron Depot for six months (you can read my experience here) and many other women have suffered from long-term effects of the drug (you can read about their lives after Lupron here). It’s not a drug I will ever take again. I feel like the harsher physical and mental side effects of the drug were not verbally disclosed to me, and it was literally the hardest regimen I’ve ever endured. It’s so much more than “chemical menopause.” If you’re interested in reading up on some of the other side effects that weren’t verbally discussed with me (literally, I was told it was “just like entering menopause”), check out the FDA’s product packet insert here (Pages 10-12 discuss adverse reactions).
AbbVie is also currently working on a new GnRH antagonist called Elagolix to treat Endometriosis and fibroids. It would be in pill form instead of an injection like Lupron. The most common-reported side effects during the clinical trials were hot flash/hot flush, nausea, and headaches. I haven’t been able to find the lesser-reported side effects. But having been on a GnRH agonist for six months and enduring a wide gambit of effects including hot flash, nausea, and headaches; I will never personally take another. I could only hope that Elagolix’s lesser-reported side effects will be equally disclosed and discussed prior to prescription and administration of the drug to patients. Reported benefits of long-term Elagolix use have been reductions in fatigue, menstrual cramps, non-menstrual pelvic pain, and painful sex.
A large part of me can’t help but think that the push for the FDA priority review, the timing of the Endometriosis commercial and the launch of the SpeakEndo webpage are financially motivated and targeting a niche market:
- 2013-present: AbbVie conducts clinical studies of Elagolix to treat Endometriosis pain and symptoms;
- May 2017: SpeakEndo.com domain name secured by AbbVie
- Sept. 2017: AbbVie seeks FDA review and approval of Elagolix;
- Oct. 2017: FDA approves a priority review of Elagolix;
- Jan. 2018: SpeakEndo commercials hit TV screens;
- July 2018: FDA approval Orilissa (Elagolix)
- SpeakEndo is owned by AbbVie, Inc.;
- AbbVie manufactures and distributes Lupron Depot and Orilissa, two medications targeted to mask symptoms of Endometriosis;
AbbVie received FDA approval for a priority review of Elagolix, shortening the usual 10-48 month approval process to an expedited 6-month approval process…meaning Elagolix could be approved as early as mid-2018. An article published on January 29, 2018, stated that AbbVie shares were “up over 100 percent over the past year” and a September 25, 2017, article stated that Elagolix was “expected to have an annual cost of therapy over $7,000” in the United States alone.
In the past, the FDA has approved prescription medications on a priority review basis, only later to be withdrawn from the consumer market. Priority review is granted for drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions” and drastically shortens the time of approval to push the drug to the consumer market. Following is a list of examples of a few drugs that were approved on a priority basis, only to be withdrawn:
- After a 9-month review, Accutane was approved by the FDA on May 7, 1982, to treat acne. Ads were placed in magazines and on TV. During the first six months of its release, physicians had written 200,000 Accutane prescriptions. As time and technology progressed, Hoffman-La Roche (the manufacturer) secured the domain names FaceFacts.com (focused on acne with teenagers) and derm-infonet.com (acne with adults), which have been described as webpages that were non-branded information sites that provided “medical information on the subject of acne and acne treatments.” In 2000, Hoffman-La Roche had raised over $7.5 million from Accutane sales alone. In 2001, the FDA Consumer Magazine said Accutane was “the biggest breakthrough in acne drug treatment over the last 20 years.” Then, in 2009 the manufacturer withdrew it due to an “increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies.” There were years of regulation reviews and hearings, as well as over 7,000 lawsuits filed by consumers.
- Abbott Laboratories created Cylert to treat ADHD/ADD targeted mostly at children and teenagers. It was approved under a priority review in 1975. Cylert was advertised in medical journals, such as the American Journal of Psychiatry, touting it’s “once a day convenience” instead of a need for multiple doses. By December 1998, the FDA reported there had been 12 confirmed cases of liver transplants and/or death caused by the drug. In 2005, a consumer group raised concerns about the safety of Cylert which was followed by Abbott discontinuing its production (supposedly due to a lack of demand and not influenced by the consumer complaints). The FDA officially withdrew its approval as Cylert was proven to cause liver toxicity and the risks involved far outweighed the benefits of the drug.
- A few Irritable Bowel Syndrome drugs have been approved by the priority review process. In February of 2000, Lotronex was approved for the treatment of Irritable Bowel Syndrome in women. Soon after it was available to the public, the FDA began receiving adverse reaction reports, including constipation and ischemic colitis. In some instances, patients required surgery due to bowel complications…or worse…died; there were reports of 45 surgeries and four deaths. Less than ten months after it’s priority review approval, Glaxo Wellcome withdrew Lotronex from the market. However, since it was considered the only drug available to help some people with their IBS symptoms, it was re-approved in 2002 and was placed back on the market with severe restrictions. In July 2002, Zelnorm was manufactured by Novartis for IBS treatment. It was aggressively promoted with TV and magazine ads. With the launch of Novartis’ “Tummies” TV commercials, they received 390,000 new patient prescriptions, claiming their ads “empowered thousands of women to talk about IBS” to their doctors. It increased their prescription sales by 90%. However, due to an increased risk of heart attack, stroke, and chest pain, it was pulled from the market in 2007. Zelnorm sales profited Novartis an estimated $560 million.
- After seeking priority review, Pfizer received FDA approval in 1997 of Rezulin. It was marketed as an antidiabetic and an anti-inflammatory medication. Due to reports of liver failure and 63 confirmed deaths, the drug was removed from the market in 2000. It had earned Pfizer over $2 billion in sales.
- In 1999, the FDA approved Merck’s drug, Vioxx, after a six-month priority review period as a drug to aid with pain, menstrual cramps, and osteoarthritis that was supposedly safer than Advil or Aleve. Magazine and TV ads featured athletes Dorothy Hamill and Bruce Jenner. They both made appearances on the Larry King Show to talk about Vioxx, clarifying that they were both paid by Merck. It’s estimated that Vioxx was prescribed to more than 20 million people. However, it was withdrawn from the worldwide market in 2004 after it was found to increase the risk of heart attacks. It’s estimated that nearly 28,000 people suffered heart attacks and/or death due to Vioxx. Merck profited $11 billion during Vioxx’s four-year sale period.
However, on April 10, 2018, AbbVie announced that the FDA required an extended review of Elagolix before it was approved for the public market. What are they reviewing that hasn’t already been discussed: data regarding liver function test results from the clinical trials needed to be thoroughly reviewed by the FDA. The FDA approved Orilissa (aka Elagolix) on July 23, 2018.
I’ve no faith in the FDA’s “priority review” process. The FDA does not conduct their own studies; rather, it depends on the studies by the manufacturers and third parties attesting to the safety, risks, and efficacy of the drugs they’re pushing.
Through my research, I’ve also learned that many pharmaceutical companies have hosted patient groups, organizations, and websites which offered an avenue of support to those who suffer from various conditions. Advertising watchdogs refer to this tactic as “Condition and Behavioral Targeted Advertising,” using unbranded sites to reach a target audience with a specific condition. It’s been described as “specialized health portals and networks specifically created to target consumers based on particular conditions or concerns” through “the use of online video and websites to raise the awareness of a particular disease or condition…designed as educational sites, where individuals can share their experiences with various treatments.” The phrase that really makes my Spider Senses tingle: “specifically created to target consumers based on particular conditions or concerns.”
Eisai, Inc., a pharmaceutical company that manufactures an anti-epileptic drug, owns www.livingwithepilepsy.com. The domain was secured in 2005, but the webpage is no longer active. In 2009, Eisai, Inc. started the unbranded site www.livingwithLGS.com, another epilepsy site which includes “treatment options, transitioning a child to adult care, videos, and tools and resources for caregivers, including a customizable Doctor Discussion Guide.” The site is still active today.
Likewise, in 2001 www.parkinsonshealth.com was launched. It was owned and run by Teva Neuroscience, a pharmaceutical company that manufactures drugs used in the treatment of (you guessed it…) Parkinson’s Disease. Teva Neuroscience even produced a brochure, claiming Parkinsonshealth.com and Parkinson’s Support Solutions were “a comprehensive support program designed to provide the financial resources, support, and education patients and caregivers need.” And the only place that Teva Neuroscience was referenced in the entire brochure? The small print at the bottom of the very last page…If the consumer wasn’t looking for it, the brochure would have read as a completely unbiased publication without any fiduciary interest. The webpage is no longer up and running.
And this sounds much like what AbbVie appears to be doing with SpeakEndo.
I’d really, truly like to think that AbbVie is only reaching out to those in need, spreading awareness of an often misunderstood and neglected disease. But my brain keeps circling back to the fear of their motivation. I truly hope their intentions in setting up SpeakEndo.com were not to prey on those who suffer and seek relief from the pain of Endometriosis, nor to gain from the seemingly-perfect timing of the projected approval and launch date of their drug Elagolix.
Regardless, I am still so very pleased that someone (even if they are Big Pharma) are out there raising awareness of Endometriosis and bringing sufferers together. I can’t say this enough: I hope their intentions are pure and their motivation is appropriate.
**Updated September 5, 2018**
AbbVie – products list
AbbVie – Elagolix product page
AbbVie – AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
AbbVie – SpeakEndo.com Terms of Service
Acne.org – How Advertised is Accutane?
AdAge – Big Pharma Finally Taking Big Steps to Reach Patients with Digital Media
AdAge – Interactive: Media & Marketing: Drug Companies Boost Online Media Buying: Roche will Spend $1 Million-Plus
Andantestudy – Teva Neuroscience’s brochure: Caring for a loved one with Parkinson’s Disease
AttorneyPages – Bayer’s Trasylol: What Really Happened?
Benzinga – AbbVie Shares Double In A Year; Leerink Moves to Sidelines
BonkersInstitute – 1996 Cylert advertisement in the American Journal of Psychiatry
Center for Digital Democracy – Drug Marketing Moves to Digital: How Pharmaceutical Companies Pitch Consumers Online
Cision PR Newswire – AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
Clinical Trials – Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain
Community Catalyst – Zelnorm: A Case Study in Why Drug Advertising is a Bad Idea
DePirro/Garrone – Zelnorm
Drugs.com – Elagolix Approval Status
Drug Enforcement Administration – Levamisol (Ergamisol)
Drugwatch – Celebrities Team with Big Pharma to Promote Drugs, Disease Awareness
Eisai – Eisai Announces Launch of Antiepileptic Drug Fycompa in U.S.
Fierce Pharma – Merck – Vioxx
Formulary Journal – Pemoline Removed from US Market
Harvard Law School – Babies, Blemishes and FDA: A History of Accutane Regulation in the United States
Lawyers and Settlements – Novartis Withdrawing Zelnorm: But at What Cost?
Los Angeles Times – The Rise and Fall of the Killer Drug Rezulin
MedTV – Is Lotronex Back on the Market?
New York Times – US Lets Drug Tied to Deaths Back on the Market
Obstetrics & Gynecology – Elagolix Reduces Fatigue in Patients with Moderate-to-Severe Endometriosis Pain
Obstetrics & Gynecology – Long-Term Safety and Efficacy of Elagolix Treatment in Women with Endometriosis-Associated Pain
Organic Consumers – Bayer: A History of Profit from Suffering
ProCon.org – 35 FDA-Approved Prescription Drugs Later Pulled from the Market
Regulatory Affairs Professionals Society – FDA Approves Pfizer’s Mylotarg 7 Years After It Was Pulled from the Market
Roche – Patient Organisations
Seeking Alpha – AbbVie Should Obtain FDA Approval for Elagolix
Tradmarkia.com – FaceFacts.com Trademark Information
US Food & Drug Administration – Cylert pamphlet
US Food & Drug Administration – Drug Approval Database – Accutane
US Food & Drug Administration – Drug Approval Database – Cylert
US Food & Drug Administration – Drug Approval Database – Lotronex
US Food & Drug Administration – Drug Approval Database – Mylotarg
US Food & Drug Administration – Drug Approval Database – Permax
US Food & Drug Administration – Drug Approval Database – Rezulin
US Food & Drug Administration – Drug Approval Database – Trasylol
US Food & Drug Administration – Drug Approval Database – Vioxx
US Food & Drug Administration – Drug Approval Database – Zelnorm
US Food & Drug Administration – Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Subcommittee Background Package
US Food & Drug Administration – Priority Review
US Food & Drug Administration – Sequence of Events with Vioxx, Since Opening of IND
US Library of Medicine – Elagolix: A Promising Oral GnRH Antagonist for Endometriosis-Associated Pain
Whois.com – Domain Name Search – Facefacts.com
Whois.com – Domain Name Search – IWalkBecause.org
Whois.com – Domain Name Search – Livingwithepilepsy.com
Whois.com – Domain Name Search – LivingwithLGS.com
Whois.com – Domain Name Search – Parkinsonshealth.com
Whois.com – Domain Name search – SpeakEndo.com
~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa