The "Band-Aid Treatment Plan" Strikes Again

Bandaids crossing into an X

If you’ve followed my blog for a while, you may have already seen the entry about c-section scars developing lumps of Endometriosis. If you haven’t already read it, you can follow the link or just know there are a lot of women that develop a painful mass in or around their c-section scar that turns out to be Endometriosis. It’s not just limited to c-section scars, but those are mostly the reported instances of scar Endo. Most of the time, that lump is removed and the symptoms fade; recurrence seems rare.

An article hit my inbox this week that had me breathing heavy. I had to take a few days to calm down before I wrote today’s entry.

You’ve likely heard of Orilissa, aka Elagolix. It’s AbbVie’s newest “treatment” for Endometriosis symptoms that was approved by the FDA in mid-2018. Much like AbbVie’s Lupron Depot, Orilissa can only be taken for a limited time and may come with a whole slew of side effects. It doesn’t stop the disease from growing or spreading, but it may suppress the symptoms of Endometriosis. For a time…so many of us in the community refer to these drugs as “Band-aid drugs.” They mask symptoms, offer horrendous side effects, and offer no long-term solution for the disease.

Anyway, on with my point:

Authors of a January 27, 2020, study published in Sage Journals wrote that treating c-section scar Endometriosis with Elagolix (aka Orilissa) may be a viable option to avoid the “potential morbidity of surgical scar revision.” They state that further testing is needed to confirm the efficacy of the treatment.

Wait. What?

Rather than the relatively simple procedure of removing the lump of disease, they’re suggesting medicating with this GnRH antagonist to “treat” scar Endo. And the fact that it doesn’t involve surgery makes it a “very attractive potential option.” Attractive?

Here’s my beef with this:

  1. Elagolix/Orilissa doesn’t treat the disease, it suppresses the symptoms. Stop the drug and your symptoms may flood on back.
  2. The side effects can be intense:
    1. May cause liver issues
    2. May cause bone loss
    3. May cause depression and suicidal thoughts. One participant in the clinical trials committed suicide two days after she stopped treating with the pill. She was 44 years old, had treated for one month, and had no medical history or life stressors that would have been indicative of suicidal thoughts.
    4. May interact with hormonal birth control
    5. Some adverse reactions during clinical trials included appendicitis, abdominal pain, back pain, hot flashes, night sweats, nausea, decreased bone mass density, headache, insomnia, mood swings, depression, lack of a period, anxiety, joint pain, decreased libido, diarrhea, weight gain, dizziness, constipation, and irritability.
  3. Depending on the dose, it can only be taken up to six months or two years

So, rather than remove the suspected Endometriosis mass within the scar tissue, they’d prefer to medicate. MEDICATE.

Ugh!

What are your thoughts? Obviously, I’m still a little heated on the topic…

Resources:

Sage Journals (Abstract, Jan. 27, 2020) – Treatment of Scar Endometriosis with Elagolix

~ 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

New Study: Elagolix vs. Lupron (Cost Effectiveness & Quality of Life)

Red apple and green apple
Comparing apples to…apples? Image by Freestocks.org

This will be a highly-charged opinion piece for me…so as you read what I am writing, please know that I am seething and upset and just needed to vent.

A study of Elagolix (aka Orilissa) hit my inbox recently and I just opened it today. It was run by Abbvie, of course. And it compares Elagolix to Lupron to see which is more cost-effective in possibly giving women with Endo a greater quality of life. So, it’s win-win for Abbvie since they make both of those drugs…

Elagolix was deemed the “winner” in that it costs patients less money and possibly grants them a greater quality of life with a possibility fewer side effects.

And why am I seething? That sounds great!

  • a) It’s the same damn company comparing two similar drugs that it manufactures,
  • b) both are laden with possible shit-tastic side effects,
  • c) both can only be taken for a minimum amount of time , and
  • d)…the best for last: San Diego’s own Dr. Agarwal is listed as an author, a consultant for Abbvie’s research, and he helped with the “inception, design, and analysis” of this study. The same Dr. Agarwal who accepted $315,000 from Abbvie from 2013-2017. And I’ve been told my many of his Endo patients that he often pushes Lupron and Elagolix for treatments.

Does it make me want to consider taking Elagolix to manage my Endo pain? Not one bit.

I was on Lupron for six months and it was one of the hardest things I’ve ever done, physically and mentally. Many people I’ve talked to had horrendous side effects and continued to have them long after quitting the treatments. And ABC 10 News interviewed several of our local EndoSisters about their Lupron experiences. It’s my understanding that Elagolix is very similar to Lupron…so I’ve zero desire to put my mind and body through such torture again…for a temporary, limited-use band-aid drug. But, I will always say this: don’t let my opinion sway you from a treatment option.

A fellow EndoSister, Magda, has a different perspective and she has given me permission to share her words today:

“I had a very good experience meeting with Dr A a few months ago finally so I don’t agree with a lot of the comments made about him. 

“I’m on a different study, for [redacted] which is similar but not one he is associated with and he thanked me for doing so even, and honestly my endo pain surprisingly enough I feel is quite nonexistent at this point, around 8 weeks in on non-placebo drug. Obviously if some saw me in a walker this last weekend it’s bc I need surgery on my hip from the labral tear because of a car accident but I’m beyond grateful that my endo is finally under control with one of the newest drugs out there for it, and with the addback therapy I haven’t seen any real side effects I’ve noted. In 2 weeks I’ll have my bone density rechecked so we can see where that is but I feel grateful to finally be on something helping control my endo pain, especially with limited side effects. 

“Since surgery is clearly not an end all option for our disease we’ve all learned maybe we should keep an open mind that there are some doctors out there that are truly trying to actually find a solution to at least help control our daily symptoms and in my opinion that is what Dr A is doing with his current practices, as a cure is not that simple. Unfortunately most diseases don’t have a cure, all kind of people take daily meds for all kind of things, like high blood pressure, diabetes, thyroid problems, high cholesterol, migraines, I could go on and on and on……trust me I get it. I literally cried my eyes out earlier this year the first day a doctor told me I was in denial that I had endometriosis and needed to be doing something about it, but mainly because I realized she was right. I also realized there are a lot worse things in life and in some case way worse conditions, especially some that don’t have a few pills that can help lower the pain levels or even possibly not help you in staying alive.

“So I count my blessings that I finally know what’s caused my pain, even though it took a long 21 painful years and a horrendous almost near death experience in the hospital last year just to get a diagnosis and finally know, but at least now I know and I’m doing something about it.

“That’s why I joined a study. To help not only myself but all the countless women who might still not know, and especially the children, more specifically the ones in my family that might be the unlucky ones to get this disease as well…..everyone has their own choices to make in life. I’ve made mine to help make a difference in any way I can. My question is what are you doing to help. If not others, at least for yourself. God put doctors and scientists on this earth to work on and help possibly eventually find cures, or at least medications that can help, that’s what the current studies out there are for. Without patients willing to help test the products, they will not be able to help us. And who knows, maybe you will actually feel better in the process. I know I do. And I at least have that to be grateful for. That’s my food for thought on this topic. “

Please, please, PLEASE do your own research and know what you’re getting into first: read the entire FDA drug pamphlets, analyze the studies, talk to others that have tried it, and question your healthcare providers. Most importantly: trust your gut. The decision is yours, and yours alone.

Resources:

Future Medicine – (Article, Feb. 2019) Cost–effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA

Orilissa: AbbVie’s New Drug to Manage Endometriosis Symptoms

Screenshot of FDA Drug Label for Orilssa
Screenshot of FDA Drug Label for Orilissa, July 24, 2018

You may have seen news articles and press releases flying around the Internet since yesterday regarding a new drug released to manage Endometriosis pain.  I wanted to share this with you because, although I’ve no intention of taking the drug myself, I know that it may help women who suffer. And it may help better educate you on your decision.

I’ve been following it for a while and you can read my thoughts about AbbVie’s SpeakEndo commercials and website, as well as their expedited application for FDA approval, and the track records of other drugs that have done the same.  And according to Business Insider, Orilissa may cost approximately $850 per month, or roughly $10,000 per year for prescriptions (I’m assuming those figures are calculated without health insurance).  Orilissa is estimated to hit markets for prescriptions in August of this year.

So, here you go:

On July 23, 2018, the Food & Drug Administration approved AbbVie’s new drug to treat Endometriosis pain. You may have seen it referred to as Elagolix, but it has been officially named Orilissa. It is an oral GnRH antagonist.

Please do your own thorough research before talking to your physician.

In the Resources section below is a link to the FDA’s drug fact sheet, which includes a .pdf of the pamphlet that should come with the drug. Read it. Review the clinical trials. And decide for yourself.   You can read the .pdf which I have downloaded, or by accessing the FDA’s site and downloading it for yourself.

It appears it has limited allowable dosing (6 months to 2 years), may cause liver issues, may cause bone loss, may cause depression and suicidal thoughts, and may interact with hormonal birth control. Some adverse reactions during clinical trials included appendicitis, abdominal pain, back pain, hot flashes, night sweats, nausea, decreased bone mass density, headache, insomnia, mood swings, depression, lack of a period, anxiety, joint pain, decreased libido, diarrhea, weight gain, dizziness, constipation, and irritability.

One participant in the clinical trials committed suicide two days after she stopped treating with the pill. She was 44 years old, had treated for one month, and had no medical history or life stressors that would have been indicative of suicidal thoughts.

Where did I get all this info? The FDA drug pamphlet.

Don’t trust me, read it for yourself.

Weigh the pros and cons.

And talk to your doctor.

A February 2019 study showed that women in Phase 3 Trials of Elagolix had improved period pain and non-period pelvic pain than those who were given the placebo pill. It stated that most adverse events were mild to moderate, but there was a risk of bone loss among patients.

And a June 2019 study showed that women in a 6-month clinical trial that were given Orilissa were at work 2-4 hours longer per week than women who were given the placebo, improving their attendance.

An October 2019 study written by Dr. Brian Ford of the Naval Hospital at Camp Pendleton shared a few warnings about Orilissa: Orilissa may decrease the effectiveness of some oral contraceptives, so non-hormonal contraception to avoid pregnancy while on Orilissa. The most common side effects that forced participants to drop out of the clinical trials were hot flashes and night sweats. There’s a risk of decreased bone density. Mood changes, depression, and/or suicidal thoughts may occur. The way the body metabolizes certain medications may be altered because of the way Orilissa affects liver enzymes. Other side effects reported in the trials were an absence of a period, headaches, and insomnia. Compared to the placebo group, after 3 months of trials, 46% of women taking the 150mg of Orilissa and 72% of those taking the higher 250mg dose had improved pain menstrual pain while on the drug. Dr. Ford stated that 28-day supply of Orilissa costs approximately $870. Due to the expensive nature of the drug, as well as the adverse side effects similar to other drugs (such as Lupron Depot), Dr. Ford recommends that ” Elagolix should be reserved for women who do not benefit from nonsteroidal anti-inflammatory drugs or hormonal therapy. ” Just a few thoughts to chew over and discuss with your physician…

We are our best advocate. Do what you feel is best for you. But, please, do it informed and do it safely.

Knowing how poorly my body handled Lupron Depot (another AbbVie product that is incredibly similar), and how I became so severely depressed and suicidal on it, I will never again subject my body to something similar.  It did nothing in the long-term to stem my Endometriosis.  And was an incredibly difficult journey while on Lupron, as well as a long while before my body cleared itself of any side effects.  That is why I choose not to take Orilissa.  The decision is an individual one.  Never again.  But, again, I will never tell you not to try something; it may very well help you cope with your symptoms.  Understand, though, that it is a band-aid.  It will mask your symptoms; not clear your body of Endometriosis.  I learned that one the hard way…

If you do your research and make a well-informed decision to start (or not start) Orilissa, I wish you all the best of luck and health.  There are no judgments here.  Only well-wishes.

And, if you wish to see a quick snapshot of the participants and findings of the two clinical trials, please visit this FDA page.

**Updated October 22, 2019**

Resources:

AbbVie – (July 24, 2018; Press Release) AbbVie Receives US FDA Approval of Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis

American Family Physician (Oct. 15, 2019; Article) Elagolix (Orilissa) for Endometriosis Pain

Business Insider (July 24, 2018; Article) A New Treatment for a Condition that Can Feel Like Tiny People Skating on Razor Blades in Your Stomach and Affects an Estimated 200 Million Women Just Got Approved

Drugs & Therapy Perspective (Feb. 2019; Abstract) Elagolix in Endometriosis-Related Pain: a Profile of its Use and Approved in the USA

Fertility & Sterility (June 2019; Abstract) Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials

US Food & Drug Administration – Drug Database: Orilissa

~ 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