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.

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 June 25, 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

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

Have you Seen the Endometriosis Commercials on TV?

Speakendo.com webpage banner
Screenshot of SpeakEndo.com; 1/30/18
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.

Am I going to sign up for SpeakEndo.com? Nope. After scrolling to the bottom, seeing AbbVie is the owner of the site, reading their privacy policy and their terms of service, I’ve no desire to embed myself with a pharmaceutical company.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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**

Resources:

AbbVie – products list

AbbVie – Elagolix product page

AbbVieAbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

AbbVie – SpeakEndo.com Privacy Policy (How We Use Your Information section)

AbbVie – SpeakEndo.com Terms of Service

Acne.orgHow Advertised is Accutane?

AdAgeBig Pharma Finally Taking Big Steps to Reach Patients with Digital Media

AdAgeInteractive: 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

AttorneyPagesBayer’s Trasylol: What Really Happened?

Azilect.com

BenzingaAbbVie Shares Double In A Year; Leerink Moves to Sidelines

BonkersInstitute – 1996 Cylert advertisement in the American Journal of Psychiatry

Center for Digital DemocracyDrug Marketing Moves to Digital: How Pharmaceutical Companies Pitch Consumers Online

Cision PR NewswireAbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

Clinical TrialsStudy to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain

Community CatalystZelnorm: A Case Study in Why Drug Advertising is a Bad Idea

DePirro/GarroneZelnorm

Drugs.comElagolix Approval Status

Drug Enforcement AdministrationLevamisol (Ergamisol)

DrugwatchCelebrities Team with Big Pharma to Promote Drugs, Disease Awareness

Eisai Eisai Announces Launch of Antiepileptic Drug Fycompa in U.S.

Fierce PharmaMerck – Vioxx

Formulary JournalPemoline Removed from US Market

Harvard Law SchoolBabies, Blemishes and FDA: A History of Accutane Regulation in the United States

Lawyers and SettlementsNovartis Withdrawing Zelnorm: But at What Cost?

Los Angeles TimesThe Rise and Fall of the Killer Drug Rezulin

MedTVIs Lotronex Back on the Market?

New York TimesUS Lets Drug Tied to Deaths Back on the Market

Obstetrics & GynecologyElagolix Reduces Fatigue in Patients with Moderate-to-Severe Endometriosis Pain

Obstetrics & GynecologyLong-Term Safety and Efficacy of Elagolix Treatment in Women with Endometriosis-Associated Pain

Organic ConsumersBayer: A History of Profit from Suffering

ProCon.org35 FDA-Approved Prescription Drugs Later Pulled from the Market

Regulatory Affairs Professionals SocietyFDA Approves Pfizer’s Mylotarg 7 Years After It Was Pulled from the Market

RochePatient Organisations

Seeking AlphaAbbVie Should Obtain FDA Approval for Elagolix

Strataco

Tradmarkia.comFaceFacts.com Trademark Information

US Food & Drug Administration – Cylert pamphlet

US Food & Drug AdministrationDrug Approval Database – Accutane

US Food & Drug AdministrationDrug Approval Database – Cylert

US Food & Drug AdministrationDrug Approval Database – Lotronex

US Food & Drug AdministrationDrug Approval Database – Mylotarg

US Food & Drug AdministrationDrug Approval Database – Permax

US Food & Drug AdministrationDrug Approval Database – Rezulin

US Food & Drug AdministrationDrug Approval Database – Trasylol

US Food & Drug AdministrationDrug Approval Database – Vioxx

US Food & Drug AdministrationDrug Approval Database – Zelnorm

US Food & Drug AdministrationGastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Subcommittee Background Package

US Food & Drug AdministrationPriority Review

US Food & Drug AdministrationSequence of Events with Vioxx, Since Opening of IND

US Library of MedicineElagolix: 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