CAMBRIDGE — More than a million Americans have filled prescriptions for Linzess since the once-daily capsule was approved by the Food and Drug Administration in 2012 to treat a condition many would rather not talk about: irritable bowel syndrome with constipation.
Ironwood Pharmaceuticals Inc. hopes to increase sales substantially with this week’s launch of a new ad campaign focusing on the drug’s benefits in relieving symptoms like abdominal pain and seeking to ease patients’ discomfort in discussing them.
The television and Internet ads, coming amid mounting criticism over consumer marketing of prescription drugs, are designed to spark conversations between patients and doctors, said Thomas McCourt, the Cambridge company’s chief commercial officer. Ironwood wants to prompt reluctant patients to ask about the drug and encourage doctors more focused on life-threatening diseases to take IBS and constipation — which can restrict patients’ lives and activity — more seriously.
“The goal is how do we help patients help themselves,” McCourt said, citing a theme that has underpinned other companies’ marketing for drugs such as Lipitor, a cholesterol medication, and heartburn-relieving Prilosec. “When I think about the most successful consumer campaigns in history, they’re all focused on the interaction between patients and docs.”
Ironwood’s commercial is a so-called product claim ad, which must list side effects and be submitted to the FDA before it airs. The assumption behind such ads is that “consumers can absorb more information about their health care than they did in the past,” said Harvard Business School professor Robert S. Huckman, who specializes in the business of health care.
But the practice of advertising branded drugs, which is not permitted in most countries, has drawn increasing criticism in recent months as the ads have proliferated. Other irritable bowel syndrome and constipation treatments were among a slew of medical ads that aired during last month’s Super Bowl 50. At the same time, scrutiny of high-priced medicines has intensified.
In November, the influential American Medical Association issued a call for a ban on direct-to-consumer marketing of prescription drugs and medical devices.
The proposed ban “reflects concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said Dr. Patrice A. Harris, chairwoman-elect of the AMA board. She also warned such marketing could fuel demand for drugs that “may not be appropriate” for patients.
Skepticism has also spread to Capitol Hill. Last month, US Representative Rosa DeLauro, Democrat of Connecticut, introduced a bill that would place a three-year moratorium on direct-to-consumer ads.
While he is aware of the criticism, McCourt argued it’s important to inform patients about medicines they could benefit from and help them ask questions and make smart decisions.
Ironwood’s ads employ a cinematographic technique known as “stop motion” that hasn’t been previously used to promote pharmaceutical products. The film is shot one frame at a time as figures are captured in a series of positions — riding a bike, enjoying a picnic, swimming in the ocean — and then run at normal speed to give the impression of movement.
In contrast to the bright and cheerful images and upbeat music track, actors in the 60-second spot sound a frustrated tone in complaining about their recurring symptoms and the advice patients are typically given about eating flaxseed, staying active, and taking laxatives.
“Tell me something I don’t know,” one actor says in a polite but jaded voice.
At the end of the commercial, an unseen narrator intones: “Talk to your doctor about managing your symptoms proactively with Linzess.”
Television ads for Linzess will run on daytime and prime-time programs on the major and cable networks. The campaign also includes print ads, which will run in cooking, travel, and consumer magazines.
The ads, like others for branded drugs, don’t mention the price. Because it is a mass-market product that can be prescribed by primary care physicians as well as gastroenterologists, Linzess costs less than the specialty medications that have been targeted in the growing consumer backlash. The wholesale acquisition cost for Linzess is $304.54 for a 30-day bottle, or about $10.15 per pill, totalling $3,704.75 per patient annually. Most patients, who are commercially insured or subsidized through company support programs, pay about $1 per day.
Ironwood, which was founded in 1998 and went public in 2010, won’t disclose how much it is spending on the campaign. Its most recent financial report estimated the combined marketing expenses of Ironwood and its Linzess sales partner, Irish-based Allergan PLC, will total between $230 million and $260 million this year. That sum includes the cost of the Linzess sales force.
Revenue at Ironwood climbed 95 percent to $150 million last year, driven by the sales growth of Linzess, the only marketed product the company has developed so far. (It also co-markets two medicines developed by other drug makers.) Ironwood posted a net loss of $142.7 million in 2015 because it continues to fund research and clinical tests on a dozen other drug programs.
While the marketing team said it had to persuade Ironwood chief executive Peter Hecht of the benefits of consumer advertising, he ultimately signed off on the Linzess campaign.
One reason: Ironwood is convinced that Linzess is now reaching just a fraction of the tens of millions of US adults who could benefit — patients suffering from abdominal pain, bloating, and eating limitations as a result of irritable bowel syndrome and chronic constipation.
An earlier ad campaign for Linzess, launched in April 2014 and updated a year later based on consumer feedback, boosted prescriptions by 20 percent over the drug’s baseline trend.
McCourt, who formerly worked at AstraZeneca, was involved in one of the industry’s first direct-to-consumer ads, for Prilosec. The woman who spearheaded the Prilosec ad is Sharon DeBacco, whom McCourt calls “a legend” in direct-to-consumer advertising. She is now Ironwood’s vice president of product promotions and helped develop the new ad campaign for Linzess.
“Our message is going to help consumers validate their symptoms,” DeBacco said. “We know their condition is difficult to talk about. No one wants to talk about their bowel patterns.”
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