Updated note (July 25, 2018): Orilissa (Elagolix) was approved by the FDA on July 23, 2018.  You may read more about that, and my thoughts, by following this link.

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

AbbVie – AbbVie 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.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?

Azilect.com

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

Strataco

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