A pharma sales army aims to increase ‘fibroid awareness’; women’s health experts brace for collateral damage

Fibroids cause pain and heavy menstrual bleeding in some women who have them, but others experience no symptoms.

Women’s health advocates have long battled for wider recognition of the problems caused by fibroids, noncancerous growths on the uterus that can cause bloating, discomfort and heavy menstrual bleeding.

Getting women to talk about their fibroids has been viewed as a way to break the stigma around the condition and encourage more research and better treatment options, beyond fertility-robbing hysterectomies.

But now, even as fibroids are poised to enter the national conversation like never before, some women’s health advocates are bracing for a potential downside from the discussion. With “fibroid awareness” on the rise thanks to a Big Pharma campaign to stoke sales of a new prescription drug, they warn that marketing-oriented messages could lead to some women to get costly treatment they don’t need and could harm them.

Drug marketers planning ‘a lot of education’

Fibroids are extremely common–some studies show most women have them at some point during their reproductive years. But they usually remain small and harmless. For those with bothersome symptoms, a range of treatment options has come on the scene to shrink or remove them.

Forthcoming hormone-blocking drugs might be a useful new tool to quash symptoms, allowing women to avoid surgery to remove tumors. The first of these, Allergan’s ulipristal, is expected to reach the U.S. next year. It’s already sold in Europe and Canada for long-term intermittent use, at a cost of about $10 per pill. Other products are in development by AbbVie and Neurocrine Biosciences.

Allergan is boasting to investors that it’s planning “a lot of education” to pump up sales of the drug, marketed in Europe as Esmya. FiercePharma reported in an interview with Allergan’s marketing chief, Bill Meury, that the company is planning to deploy an “army” of 300 sales reps to call on obstetrician/gynecologists and a direct-to-consumer ad campaign including TV, print and social media that will put its drug “front and center.”

Allergan is laying groundwork by funding a patient advocacy group, the White Dress Project, which is trying to establish a national “uterine fibroid awareness month.” The founder of that advocacy group is featured in the first of a series of video patient stories Allergan says will “help build awareness of the fibroid patient journey.”

“So many women with fibroids suffer in silence, assuming it’s a normal byproduct of being a woman, and that there is little that can be done,” White Dress Project founder Tanika Gray Valbrun said in an Allergan news release. “It’s very encouraging that an organization like Allergan has stepped up to help us drive the much-needed disease-state recognition, which will help more women feel supported by a community that better understands the suffering they may experience with fibroids.”

Gray Valbrun, whose LinkedIn profile describes her as Content Producer at CNN, did not return a call requesting comment.

‘It’s not a public health message. It’s a sales message.’

No doubt some women with symptomatic fibroids need more support and understanding. But while patient groups have good intentions, drug companies often push messages that stoke unwarranted fears and expand the definition of disease in order to make normal conditions seem like they require treatment.

Cindy Pearson

Allergan’s video heralds the fact that 26 million U.S. women “could be affected by uterine fibroids,” and millions “may experience associated symptoms or health issues.” But it doesn’t say how many of those women might actually benefit from a new treatment option. Again, experts say that most women with fibroids don’t require treatment at all. 

Women have suffered harm from industry-funded awareness campaigns for years, noted Cindy Pearson, executive director of the National Women’s Health Network, an advocacy group that does not accept money from drugmakers, device companies or health plans.

“It sure looks like Allergan is over-promoting, which almost certainly leads to use by people who don’t need it and for whom the benefit really hasn’t been shown,” Pearson said. “It’s not a public health message. It’s a sales message.”

So far there’s limited safety data on ulipristal. The longest safety study followed just 64 patients for an average of four years. It had no comparison group, used only patients that had already been successfully treated with the drug, and was funded and designed by the drug’s European distributor, which had an obvious interest in getting a positive result. Moreover, only four percent of the patients in that study were black women. As a group, black women are much more likely to have severe fibroids than white women.

More studies are needed to show how well it works for minority women, cautioned researchers at Whipps Cross University Hospital in London, who wrote that “there is no outcome evidence for women to make informed choices for their individual circumstance.”

Pearson hopes the Food and Drug Administration will conduct an advisory committee meeting on Allergan’s application, which would make public more information on the evidence for its safety and efficacy including independent analyses.

Fertility fears are a perfect target for marketers

A public education campaign — even one funded by the drug industry — could be helpful if it wipes away the taboo of talking about menstrual problems, helps women access appropriate care, and raises awareness of all available treatments, said Karen Carlson, M.D., director emerita of Women’s Health Associates at Massachusetts General Hospital, who’s a HealthNewsReview.org contributor.

But Carlson added in an email: “It is not clear that the [Allergan] PR campaign will meet these criteria: there is a strong commercial incentive to skew the information in a direction that leads women to specifically seek this drug at the exclusion of other options.”

One big concern, Carlson said, is whether drug marketing will “amp up” concerns about the unclear impact of fibroids on fertility. The effects of fibroids on fertility are complex, she said, and depend on their size and location.

Karen Carlson, MD

“Women who want to have a baby in the future are often highly motivated to protect and enhance their fertility, and are perfect targets for marketing campaigns that offer new products and services to help them do so,” Carlson said. “It’s unclear whether the [Allergan] campaign will veer in the direction of pushing ‘early detection’ (and treatment) of fibroids to protect future fertility, but to the extent that it does, that will raise questions about whether its intent is to raise awareness or sell its product.”

An Allergan spokesman wouldn’t say whether the company intends to market ulipristal as a way to protect fertility. He sent a statement saying the FDA’s ongoing review of the drug means it’s “premature and inappropriate at this time to comment on specific commercial or promotional plans.”

But Allergan has already recruited a fertility doctor to promote the product. She was quoted in a news release touting its application to the FDA:

Uterine fibroids have a serious impact on public health, and I am hopeful ulipristal acetate will offer millions of women a new, non-surgical treatment option that will help them manage their uterine fibroids,” said Millie A. Behera M. D., FACOG, Reproductive Endocrinology and Fertility Medical Director, Bloom Reproductive Institute. “It is welcome news for physicians to learn about the possibility of an oral treatment option, and that’s exactly what U.S. physicians can look forward to if the investigational drug ulipristal acetate is approved for abnormal uterine bleeding in women with uterine fibroids.”

Patient stories as stealth promotion

Fear is an effective marketing strategy, and it can have dismal consequences. In the 1990s makers of osteoporosis drugs pushed for screening that led many women with slightly diminished bone mineral density to believe they were at risk of breaking a bone and needed to take drugs. As it turns out, those drugs provided only modest benefits yet caused serious consequences, including increased risk of some rare but serious bone fractures over time.

Similarly, portraying menopause as a scary time of hormone depletion revved up demand for hormone replacement therapy, which was eventually linked to a moderate increase in women’s risks of some bad outcomes such as stroke, dementia and breast cancer death. The drugs were supposed to reduce menopausal symptoms such as hot flashes, vaginal dryness and night sweats but with goading from the drug industry, physicians expanded their prescribing for “off-label” uses not approved by regulators, such as protection against heart disease.

Patient stories including celebrity endorsements allow drugmakers to promote fear and expand the sale of drugs beyond their proven uses, Pearson said. “It’s a way of conveying exaggerated messages that a company itself wouldn’t get away with saying (because of FDA oversight). A patient can say whatever she believes, whether that’s backed up by science or not,” Pearson said. “And our empathy leads us to want to believe them.”

Often these stories get echoed in the media.

Will fear-mongering coverage cross the Atlantic?

Coverage that exaggerates the impact of fibroids has already shown up in Europe, where Allergan’s drug has been available since 2012. An article in the London Daily Mail depicted a woman with a distended stomach, entitled “Agony of woman who battled tumors that plague 1 in 3 women — and can wreck lives.” It touts Esmya as a drug that can “spare thousands of women from invasive surgery.” An article in the UK Express called Esmya a “miracle pill” and focused on the story of one woman with severe fibroids who credits the drug with saving her fertility.

There’s good reason to expect an uptick in U.S. coverage of fibroids. HealthNewsReview.org recently reviewed a Wall Street Journal article, “New Treatment for Fibroids Without Surgery,” that did an excellent job of exploring the many different options available to treat this condition — and emphasizing that most women with fibroids don’t need treatment. However, it didn’t disclose Allergan’s backing for the White Dress Project, whose founder was featured prominently in the coverage. (Our reviewers were also unaware of Allergan’s support at the time they conducted their review.)

A Philadelphia Inquirer business story, “Hoping for FDA approval: The first pill to treat bleeding from uterine fibroids,” focused mainly on the drawbacks of other fibroid approaches and leaned heavily on an Allergan news release. Independent sourcing may have helped balance the story with a caution about the potential for overtreatment.

What to Look for in Fibroid Stories

The prospect of a forthcoming FDA approval will likely keep fibroids high on health care journalists’ radar. Here are steps reporters can take to provide proper context — and which consumers should be looking for in any story about new fibroid treatments:

  • Report the absolute number of women who stand to benefit from treatment, not the relative numbers. That can mean digging beyond the data given in a news release, which may communicate information in ways that make a small benefit appear significant. Ask whether data varies by race.
  • Explain whether there’s good data to show a drug is safe, particularly if it’s approved for long-term use rather than a one-off prior to surgery.
  • Emphasize that most fibroids don’t require treatment, and fibroids shrink on their own during menopause.
  • Ask whether physician, patient and celebrity advocates receive money or gifts from the drug’s maker or earn money from fibroid treatments of any kind. Be sure to include perspective from experts with no ties to the pharmaceutical industry.

With fibroids, it’s also important not to succumb to scary language.

“It isn’t contagious, and it is not a growing problem. It’s just problematic for a decent number of people,” Pearson said. “If pain and heavy bleeding aren’t bothering you, turn the page.”

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