Beverly J. Lybrand, Merck Vaccines

By now, you’ve probably heard the heated arguments for and against Merck’s introduction last year of Gardasil-the first, and so far only, vaccine that protects women against the human papillomavirus (HPV), a surprisingly common sexually transmitted disease that is the leading cause of cervical cancer in women. An April op-ed in the Detroit News, for instance, charged that the vaccine promotes promiscuity and “devalues personal morals.” Meanwhile, an editorial in the Sarasota Herald-Tribune in March called Gardasil a “wonder drug” and marveled that it could possibly prevent a cancer.

The fact that people are still going to be talking about the vaccine for quite some time is a tribute to Merck and its lead Gardasil marketer, Beverly Lybrand.

While critics have questioned Merck’s role in the public health policy arena, few would argue with the stellar results that Lybrand’s overall marketing strategy has produced. From spearheading physician and professional medical group education to creating a consumer ad campaign featuring inspirational bracelets and stirring TV ads that struck a chord with the female population, her efforts have driven one of the most successful product launches from Big Pharma in recent memory.

For Lybrand, who serves as Merck’s vp/general manager of the HPV franchise, the motivation went beyond the imperative to boost the company’s bottom line. Rather, it was an opportunity for her team to make a public-health contribution of epic proportions.

“When we looked at the clinical data, it was very clear to me we had something that could bring tremendous value to women and drive significant benefit to the company,” she said. “We recognized the potential global health impact of the vaccine well before the launch.”

Thanks in large part to Lybrand’s efforts, that launch has turned heads well beyond the pharmaceutical industry. Gardasil, which made its U.S. debut in June 2006, generated $452.2 million in the first six months of 2007, with 54,000 prescriptions dispensed, per IMS Health, Plymouth Meeting, Pa. (total first-year sales were $628 million). Recently, Merck increased its year-end profit forecast based on higher net Q2 sales, up 12% to $6.1 billion, partly on the strength of Gardasil. At its current growth rate, Gardasil may well join the likes of Lipitor, Celebrex and Viagra as rarefied drug brands that have reached the $1 billion annual sales mark within their first two years.

“Merck found a way to open a dialogue between mothers and daughters on a difficult subject,” said Gary Stibel, partner at New England Consulting Group, Westport, Conn. “Considering the nature of the problem, they did a very good job of walking the tightrope.”

Not surprisingly, Wall Street, too, is enamored with the vaccine. Some analysts are predicting sales of the brand as high as $4 billion a year. For comparison’s sake, consider that only the top two brands in the $275 billion prescription drug category last year had higher sales: Pfizer’s Lipitor, with $8.6 billion, and Nexium’s AstraZeneca, with $5.1 billion. Gardasil isn’t nearly there yet, but it’s off to an excellent start.

“The success has been spectacular, though it might have been predicted,” said Anthony Butler, Ph.D, an analyst with Lehman Brothers, New York. “Remember, this is a vaccine that prevents cancer. That is a first.”

A PERSONAL CALLING

Lybrand, 50, has been with Merck since 1989. She began working on Gardasil in 2004, having made her mark on the Singulair launch back in 1998. A former healthcare employee who started out in nursing at Thomas Jefferson University Hospital in Philadelphia, she has a personal connection to her business. “My dad died of a heart attack at the age of 45. That’s when I became acutely aware of the importance of health,” she said. “There a lot of people in the industry who are provider-oriented, and they come here because they want to make a difference in people’s lives.”

Today, Lybrand is responsible for the global Gardasil business and leads a cross-functional team that includes clinical, regulatory, sales and marketing executives.
She reports directly to the president of Merck’s vaccine division, Margie McGlynn.

During Gardasil’s launch phase, Lybrand was more involved in day-to-day operations-for example, by giving the green light on all advertising materials- than she is now. But colleagues remember and praise Lybrand for outlining a clear set of goals without necessarily insisting on a specific course of action to achieve them.

“She is one of the best strategic thinkers I’ve worked with,” said David Schechter, a 15-year Merck veteran who has overseen Gardasil’s U.S. marketing since August 2006. “She’s aggressive in putting teams together and outlining objectives. She asks the right questions and allows you to focus on the right things. If you need her input, she’s always there for you. But she doesn’t stand in your way.”

“I participate in key customer actions, but I generally try to let people do their jobs,” Lybrand explained. “As a leader, it is important to have an action orientation and move with decisive speed when it is required.”

YOUNG WOMEN SPEAK UP
Perhaps no better example of Lybrand’s drive and creative orchestration exists than Gardasil’s “One Less” TV campaign, which debuted last fall. In the emotion-laced campaign from DDB, New York, a group of defiant girls announce that they want to be “one less” victim of cervical cancer. These characters are not depicted as victims, of course, but rather as budding young women taking control over their health and their lives.

“Bev urged us to go through all of the faces and asked whether they were expressing what we wanted them to,” Schechter recalled. “That led to some changes in the people used in the ads. As a result, we created a much stronger message of empowerment.”

Filmed in a gritty, documentary style, the ads intersperse information about Gardasil between scenes of teenagers at play or hanging out on city streets. One spot opens with a female skateboarder; another features a boxer. Images stream by of girls hanging out together or with their mothers, who, along with narrators, delineate the limits of Gardasil and potential side effects of the vaccine.

The ads are poignant, yet possess an air of authenticity that’s often lacking in the drug category, where brands often struggle to find an appropriate voice without eliciting groans from viewers (think: ads for erectile dysfunction or bladder control).

“We looked for women who felt genuine, down-toearth and confident,” said Ellen Fields, worldwide account director at DDB. “We had a very focused and strategic premise: developing creative that had impact but was appropriate from a regulatory standpoint.”

This year, Merck spent $127 million on advertising for Gardasil through July, per Nielsen Monitor-Plus, a hefty investment that has been returned several times over in the brand’s explosive sales. Meanwhile, the campaign- including a round of unbranded, testimonialstyle spots in which women on the street urge viewers to “Tell Someone” about the link between HPV and cervical cancer-has picked up several advertising awards and draws glowing praise from industry peers.

“It is consumer healthcare advertising at its finest,” said Nick Colucci, president and CEO of Publicis Healthcare Communications Group, New York. “It provides balanced information and motivates the public to seek an intermediary to make an informed decision on an important issue.”

Lynn Benzing, CEO of Patient Marketing Group, Princeton, N.J., agreed. “Establishing trust is critical for pharmaceutical companies, and one way to do that is to provide straightforward information about your product,” she said. “Gardasil tackled a number of taboos in a competent, professional manner.”

Gardasil used other methods to connect, literally, with young women. As part of a pr campaign unveiled by Edelman, New York, last spring, over 1.5 million bead kits have been distributed via the Internet and local market events that could be assembled into cervical cancer awareness bracelets dubbed “Make the Connection” and, later, “Make the Commitment.” The latter tag is also the URL of an informational Web site that has drawn more than 2.6 million unique visitors.

Merck also funded PSAs, developed by the Cancer Research and Prevention Foundation, and starring actress Kimberly Elise. Gardasil’s other celebrity spokespeople have included Susie Castillo of MTV’s TRL and Stacy London of the cable fashion reality show What Not To Wear.

Additionally, Merck has targeted physicians, for example, with a four-page ad insert-via
Juice, New York-that has been running in medical journals, including American Family
Physician and the Journal of the American Medical Association. The insert features information on Gardasil interspersed with illustrations of girls conversing and hanging out in a public park.

SEXUAL POLITICS

All of these efforts supported Gardasil’s mission to bridge a huge awareness gap: Less than 5% of female consumers previously knew of HPV’s link to cervical cancer, according to Merck. Widespread acceptance of a vaccine in the U.S., meanwhile, derives in large part from the recommendations of the Advisory Committee on Immunization Practices, a governmentfunded panel that works closely with the Centers for Disease Control. A nod from the ACIP puts a vaccine into the CDC’s Vaccines for Children insurance program, a critical designation as the VFC covers vaccinations for 45% of all children in the U.S.

In approving Gardasil last June, the Food and Drug Administration indicated it for females ages 9-26, while the ACIP recommended HPV vaccination at ages
11-12. Either starting point, of course, is far younger than most parents would like to believe their daughters are engaging in sexual activity.

To help alleviate some concerns, Rick Haupt, M.D, executive director of Merck’s vaccine and infectious diseases unit, provided the ACIP with research data on safety and efficacy of Gardasil. He also conducted outreach with15 professional medical organizations.

“We had to tailor our education efforts to different provider groups and integrate them so they could talk to one another,” said Haupt. For example, he noted, “A gynecologist can tell a pediatrician how bad HPV is for women, but the pediatrician has to explain how to get children into a vaccination program.”

Still, many people remain uncomfortable with the influence that drug companies wield over public policy in this country. Supporters of school-entry vaccination laws say that, regardless of Merck’s lobbying,
those provisions have been proven to increase immunization rates and neutralize economic disparities among the uninsured (noteworthy for Gardasil, which costs on average $360 for the three shots).

All manufacturers are involved in this process to some extent,” said Dr. Lance Rodewald, director of immunization services at the CDC.

“The best approach is for drug companies to consult state health departments, which work directly on the implementation of vaccines. That way, it looks less like the company is legislating the practice of medicine.”

Lybrand doesn’t dispute the legitimacy of that counsel, though she does not wish to re-do the past. “When we talk about interacting with states at the government level, our actions have always focused on one thing: education. The message was, ‘Here’s what you should know about the virus.'”

As for entering into the realm of sexual politics with Gardasil, Lybrand knew that Merck risked tripping that particular land mine in the culture wars.

She notes that her own daughter began receiving the shots at age 14, and that school vaccination laws typically include an opt-out clause for those who object on religious or moral grounds. Many on the other side of the debate say the laws should be written to provide insurance coverage but reversed to include an “opt-in” clause.

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