When the makers of Elmiron were thinking of Elmiron marketing, they were looking to increase visibility for their drug. In order to market Elmiron, they used traditional medical provider and direct to consumer advertising. But, they also found a unique way to market Elmiron by focusing on the disease indication, Interstitial Cystistis (IC) and its effects on the professional career of 3-time LPGA Tour winner Terry-Jo Myers.
For big brands and companies, finding innovative marketing strategies and experimenting with new tactics can cost a lot of time and money. As a result, many companies look toward professional athletes to be influencers and endorsers of their products. Because of their athletic prowess and ability to unite fans, athletes have proven to be the perfect gateway for companies to reach their targeted demographic. Below you will find more information on the significance of Terry-Jo Meyers and other marketing ideas influences the popularity of this dangerous drugs.
History of Elmiron Marketing, An Orphan Drug
Elmiron was initially designated an “orphan drug” through the Food and Drug Administration’s (FDA) Orphan Drug Act in August 1985. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. The sponsor of Elmiron, Alza Corporation, was acquired by Johnson & Johnson in 2001.
For a drug to qualify for orphan designation both the drug and the disease or condition, must meet certain criteria specified in the ODA and FDA’s implementing regulations. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing.
A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee, unless the application includes an indication for other uses, other than for the primary condition for which the drug was designated.
Getting Elmiron Out to Patients and The Need for Elmiron Marketing
Elmiron was approved for relief of bladder pain or discomfort associated with interstitial cystitis. A year later in 1986, Elmiron was made available on a compassionate use basis, this meant that the drug could be prescribed to seriously ill patients even though it had not yet been approved.
After numerous denials of their New Drug Application (NDA) with the FDA beginning in 1991, Baker Norton Pharmaceuticals received full FDA approval for Elmiron in October 1996. Baker Norton was a subsidiary of the Ivax Corporation, which later became Teva Branded Pharmaceutical Products.
Baker Norton and Alza Corporation had a difficult task on their hands; they had to market an orphan drug to physicians who were skeptical about the existence of interstitial cystitis as a disease and the number of patients who would need the drug was slim. Alza developed a multi-tiered approach to market not just Elmiron but the disease of IC. They teamed up with Deeter USA, an integrated marketing and communications company in Pennsylvania. Deeter described the work it did for Baker Norton and Elmiron marketing on its website:
When Baker-Norton Pharmaceutical Company asked for our help in launching Elmiron, an orphan drug introduced to battle interstitial cystitis (IC), it was clear we were facing an uphill battle. The company had no sense of market size, they had little experience marketing to consumers, the budget was minimal, and physicians were skeptical that IC actually existed as a disease.
It took us nearly two years, yet in partnership with the Interstitial Cystitis Association and LPGA golf professional Terry-Jo Myers, we were able to introduce IC to the general public and create a push-pull dynamic between consumers and their physicians, proving the problem actually existed and that Elmiron was very effective treatment for it. What made this project so interesting was the fact that we were successful despite having limited resources. Instead of competing with other pharmaceutical companies and other products on the health pages of leading newspapers and magazines, our story ran on the sports pages of those same national publications as well as on those radio and television networks that prized themselves on their coverage of golf.
What we did with IC and Elmiron set the standard that others still follow.
The primary marketing issues associated with Elmiron were low public and provider awareness of IC, and the limited nature of available data on efficacy. To combat these marketing issues and promote Elmiron, Alza conducted advisory board meetings and teleconferences, dinner meetings, speaker programs, conventions with urologists and OB-Gyns, and worked to get IC articles published in medical journals.
Elmiron’s Direct to Consumer Advertising, The Second Step Taken for Elmiron Marketing
Direct-to-consumer pharmaceutical advertising (DTCPA) can be defined as an effort (usually via popular media) made by a pharmaceutical company to promote its prescription products directly to patients.
The U.S. and New Zealand are the only countries that allow DTCPA that includes product claims. Most other countries do not allow DTCPA at all; however, Canada does allow ads that mention either the product or the indication, but not both.
To market Elmiron directly to consumers (70% of whom were women) Baker and Alza used drug assistance programs to help with costs, a toll-free helpline, a VHS program with expert advice, cookbooks, voiding and diet logs, and a website which featured Terry-Jo Myers and her battle with interstitial cystitis.
Terry-Jo Myers Uses Her Platform to Vigorously Promote Elmiron
Terry-Jo Myers first mentioned using Elmiron in an interview with the Associated Press in June 1996, 4 months before Elmiron was officially approved by the FDA. In the article titled “After Years Of Pain, Myers Finally Putting Her Life Back Together,” the writer explains Myers’ struggle with pain from IC and what she has done to improve her symptoms:
Actually, Myers is one of the more fortunate ones. Two years ago, she began taking the drug Elmiron, which produces a protective lining on the bladder wall. Not yet approved by the Food and Drug Administration, it works in only about 33 percent of the patients. Now, Myers leads a relatively normal existence. But she’ll never forget.
A year later in September 1997 Myers was profiled in People Magazine where she discussed her role as the spokesperson for the Interstitial Cystitis Association and testimony before congress and once again, her use of Elmiron made it into the article:
But five years ago, Myers met urologist Dr. William Evans, who altered her diet, then put her on a drug called Elmiron. The results have been dramatic. “I have no symptoms now,” says Myers, who can go four or five hours between bathroom visits.
On January 8, 1998, Terry-Jo Myers testified as an interested party on behalf of the Interstitial Cystitis Association before the Department of Labor, Health and Human Services concerning 1999 Appropriations. She requested additional IC funding, being sure to mention Elmiron throughout her speech.
The next month, she appeared again this time in the Los Angeles Times where her use of Elmiron was linked to her success on the golf course. In June 1998, the medical journal Urologic Nursing featured Myers where it was once again mentioned that she took Elmiron:
Three years ago, Myers began treatment with an oral medication called Elmiron® (pentosan polysulfate sodium), which has been granted marketing clearance by the U.S. Food and Drug Administration. Since beginning this treatment, her symptoms have improved significantly. “Though I am immensely grateful for my reclaimed success, there are many others who have not been as fortunate,” Myers said.
In September 1999, the Interstitial Cystitis Network hosted an online Support Chat for women suffering with IC. Myers plugged Elmiron over a dozen times. When asked by an attendee if she planned to take Elmiron the rest of her life, Myers replied, “Yes, until they tell me otherwise.”
PR CAMPAIGN – “ON COURSE FOR BETTER HEALTH”
By July 2001, Alza had partnered with the American Foundation for Urological Disease (now American Urological Association Foundation) to launch “On Course for Better Health,” a “national public awareness campaign” featuring Myers.
The campaign was launched during a high-profile LPGA tournament in Phoenix. Following a successful launch, the Alza PR team identified three additional high-profile LPGA tournaments. Myers would speak to media about her experience with IC, and Alza would foster relationships with local physicians.
The objective for publicity efforts surrounding the “On Course for Better Health” campaign was to increase awareness about IC and Elmiron among consumers. For the national launch, Alza paired Myers with Dottie Pepper, an LPGA champion and long-time friend of Myers’, to capitalize on Pepper’s celebrity and increase the campaign’s visibility.
Middle-aged women make up the majority of IC patients. Therefore, 38-year-old Myers and 35-year-old Pepper made ideal spokespeople for the primary audiences— IC patients, IC sufferers who had not been properly diagnosed, and people who might know someone with IC.
A separate campaign also targeted physicians (including general and family practitioners), internists, Ob/Gyns, and urologists, as a secondary audience to educate them regarding the proper diagnosis of IC.
Bayer’s Role in Elmiron Marketing
By October 2005, Bayer Pharmaceuticals Corporation and Ortho-McNeil Pharmaceutical, Inc. entered into a limited co-promotion agreement related to Elmiron. Under the Agreement, which terminated in 2011, Bayer was given the right to market and promote Elmiron to the US urology sector. Pursuant to the terms of the Agreement, the named Janssen Defendants in the Elmiron litigation have agreed to defend, indemnify, and hold harmless the Named Bayer Defendants for any claims related to Bayer’s promotion, marketing, or sale of Elmiron during the time the Agreement was in effect.
It is unknown whether Myers had any knowledge of Elmiron’s effect on users’ vision nor is there any evidence that Myers suffered any injury or damage to her vision after taking the drug. Her most recent public appearance was at Florida State Golf Association’s Senior Women’s Open in August 2018.
Understanding Elmiron’s marketing is crucial to understand the amount of targeting they did, and how strategic they were getting their drug out to people. Unfortunately, this successful marketing campaign, meant health issues for the many users. To keep updated on Elmiron and other mass tort cases subscribe to MTI’s newsletter.
Written by Christopher O’Connor
About the Author
Christopher O’Connor, Esq., is a licensed attorney (N.Y.) and a longtime journalist. His areas of focus include mass tort practice, employment law, enterprise technology, mental and spiritual health, and law practice management. He also possesses CIPP/US certification as a privacy professional.