As noted in part one of this series of four articles, Setting the Stage, in 2006, Merck captured worldwide attention with the introduction of what is often touted as the first ever vaccine against cancer. Effective against two strains of Human Papillomavirus (HPV) that account for 70% of cervical cancer cases, the vaccine shows real promise for reducing HPV infection in women.

These articles are not primarily about the efficacy of Merck's vaccine, Gardasil, or of GlaxoSmithKline's competing vaccine, Cervarix, which has not yet received FDA approval. Dr. Diane Harper, who has studied HPV for twenty years and worked on the drug trials for both vaccines, told me emphatically that "The vaccines are good and will indeed prevent cervical cancer." But Dr. Harper has serious concerns about Merck's marketing juggernaut, and the push for vaccine mandates for middle-school aged girls.

"I'll give Merck credit – there is absolutely nothing factually incorrect in Merck’s advertisements. But the interpretation of the rock stars, and the media, and of everyone else is that this vaccine will completely eliminate cervical cancer. I’ve worked with ABC, with NBC, and even on their nightly news, their headline is 'HPV vaccine prevents cervical cancer.' It's true, that is a true headline, but it is not accurate."

What has not been done to date is to separate the real value of the vaccine from the PR push to benefit Merck's bottom line, and to track the players involved in hyping the issue and pushing for mandates. In this, the second article in a four-part series, we'll look at the marketing and "education" campaigns, how they have been interpreted and implemented and the risks involved.

Viral Marketing (Literally)

As discussed in the first article of this series, Merck is in the enviable position of having the first HPV vaccine on the market. Even without state governments making vaccination required through mandates, there is undoubtedly a robust market for a drug that is being heralded as one of the medical miracles of our time, especially with a 16 to 19 month lead on its closest competitor.

Merck used their deep pockets to make sure that even before the FDA had approved Gardasil, there was a growing awareness of and concern about -- one might even say fear of -- HPV among U.S. women. The marketing juggernaut was multifaceted and meticulously planned. In 2005 Merck started by funding a campaign called "Make the Connection," which was run by the Cancer Research and Prevention Foundation (CRPF) and the celebrity charity Step Up Women's Network. The national campaign was launched September 30, 2005, in Tampa, FL, with what would become the standard formula of a celebrity, a medical professional, and an opportunity for attendees to bead their own "Make the Connection" bracelets. Partnering with non-profits, especially non-profits that appears to have patients' health and women's issues as their primary concerns, helped Merck reach audiences that may have rightly been suspicious of the motivations of a pharmaceutical company. But with even cursory examination, CRPF looks like a drug industry funded group wrapped in non-profit clothing.

According to their website, CRPF was founded in 1985 by Carolyn Aldigé a year after she lost her father to cancer. As is often the case with patient groups, CRPF's 2006 annual report lists several pharmaceutical companies, including Merck, GlaxoSmithKline, Pfizer, Roche, Eli Lilly, and Sanofi-Aventis as funders. In fact, all of those and more gave in excess of $100,000 to the organization during 2006, with several others giving at only slightly lower levels. In addition, CRPF received more than $100,000 from the industry lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) in 2006. CRPF needs to be bringing in big grants: according to their 2006 IRS 990 filing, available at Guidestar, as President of CRPF, Aldigé makes $256,000 a year and has a total compensation package of more than $286,000 annually.

Katherine Heigl of "Grey's Anatomy" sports a Make the Connection bracelet at the 2006 NAACP Awards.Merck's other campaign partner, Step Up Women's Network, describes itself as a "nonprofit, membership organization dedicated to strengthening community resources for women and girls." Demonstrating the healthy self-esteem that they want to promote in young women, SUWN immodestly states that "by making philanthropy accessible to every woman at any level, Step Up Women's Network should be the first organization that women think of when they think of making a difference." Likely aided by founder Kaye Popofsky Kramer's past as a talent agent, SUWN boasts a roster of celebrity supporters that includes popular U.S. TV and movie actors Jessica Alba, Courteney Cox-Arquette, Geena Davis, Brooke Shields, Aisha Tyler, Kerry Washington, Anjelica Huston, Jane Kaczmarek, and Marg Helgenberger. This celebrity pantheon served "Make the Connection" well. On the SUWN website, there is a video montage of celebrities hitting the news and talk show circuits plugging the campaign and the bracelets made to somehow illustrate the link between the HPV virus and cancer. Celebrities adorned their red carpet and Hollywood party garb with the bracelets, and visitors to the Make the Connection website could order a free bracelet kit. The montage estimates that 563 million people were reached by the TV spots and print coverage in Elle, Redbook, Self, People, Women's Health and many more popular magazines.

"Make the Connection" was eventually transformed into "Make the Commitment." Also produced by CRPF and SUWN with funding from Merck, "Make the Commitment" nudged women along the path of demanding Gardasil when it would be FDA approved and available, as well as offering the ubiquitous bracelet kits. A list of events around the country from late 2005 through summer 2006 notes appearances by celebrities and medical professionals that also include beading activities for attendees to make their own bracelets. At the "Make the Commitment" website, women are challenged to sign the following pledge:

"I, (your name), am making the commitment to talk with my healthcare professional in January about ways that I can prevent cervical cancer, including getting regular cervical cancer screenings."

Since January is designated as Cervical Health Awareness Month in the U.S., this pledge to talk with their doctors about cervical cancer would ensure that medical practitioners were being approached from all sides -- from Merck's drug reps, from patients, and with any luck, by state legislators. Always generous to those that serve them, the site states that for each commitment made, Merck would donate one dollar to CRPF, up to $100,000, for cervical cancer awareness and screening programs.

So far, Merck had encouraged women to "Make the Connection" and "Make the Commitment." Those were low-key efforts compared to the most significant pre-approval effort -- the "Tell Someone" commercials. This is not a new technique by any means. In his 1928 classic, "Propaganda," father of the modern PR industry Edward Bernays described at length how it is not enough to sell a product. Instead, you need to sell the vision that will lead to desire for the product, with the consumer believing that it is their own idea. The "Tell Someone" spots did not mention Gardasil since it was not yet FDA approved, but did include Merck's name and logo. They showed actors portraying everyday women being shocked that HPV is so prevalent and that there is a link to cervical cancer. "I was stunned at how many people have HPV. I was stunned. Millions? That's insane," says one woman. With a sense of urgency, all the women pledge to tell someone they love, while pointing to a speech bubble on their plain white t-shirt that says "Tell Someone."

Tell Someone commercials can be seen online at Merck's HPV website. Click to view ad.

In a May 2006, article, Bloomberg News' Angela Zimm and Justin Blum noted that not everyone was taken in. "Gary Ruskin, executive director of Commercial Alert, a consumer group based in Portland, Oregon, that is critical of drug company advertising, said Merck's promotional Web site on the viral connection to cervical cancer is 'deceptive and dishonest. Merck doesn't tell you why the site exists, which is to sell Gardasil,' Ruskin said." Kelley Dougherty, the Merck spokeswoman, protested that the campaign wasn't about Gardasil. "This campaign is part of a broad and longstanding Merck public health commitment to encourage education about the disease."

However, the Bloomberg article also cited Richard Haupt, executive director of medical affairs in Merck's vaccine division, stating that the company has "invested in public affairs and consumer education more than we've done for any vaccine in the past." (emphasis added.) The Bloomberg reporters calculated that Merck spent $841,000 for Internet ads on HPV's link to cervical cancer in the first quarter of 2006 alone. In April 2006, they bought 295 TV advertising spots for the HPV campaign, followed by 788 spots in May. It wasn't until June 2006, that the FDA approved Gardasil.

The Current Campaign

Advertising for Gardasil has not slowed. Once the FDA approved Gardasil, Merck could finally make their message overt: "Learn about HPV and cervical cancer, and be sure to ask for our vaccine by name." On November 13, 2006, Merck announced the launch of its direct-to-consumer advertising campaign "One Less," consisting of television, print and online ads. The upbeat commercials feature young women and girls engaged in a variety of activities – playing soccer, shooting baskets, skateboarding, drumming, and dancing – saying that they want to be "one less statistic," "one less woman who will battle cervical cancer." Young women are shown writing "one less" on a gym shoe, and appliquéing "one less" on the front of a hoodie. Young girls jumping rope at the end chant "I want to be one less, one less! O-N-E-L-E-S-S!" While some of the girls are pictured with parents or other adults, the message is clearly meant to be girls talking to other girls.

Merck and Edelman, Take a Bow

The PR genius behind all stages of Merck's HPV and Gardasil campaigns is the PR giant Edelman. The world's largest independent PR firm, Edelman boasts more than 2,100 employees working in 46 wholly owned offices worldwide, plus the additional resources of more than 50 affiliates. They report $299 million in revenues for FY 2006. In addition to Merck, Edelman works on behalf of the industry lobby group PhRMA, as well as some of the largest pharmaceutical companies, including AstraZeneca, Novartis, Pfizer, Abbott Laboratories, and Johnson & Johnson. They proudly promote their health-related expertise as being adept in pioneering "health relationships with health care companies, advocacy organizations, foundations, NGOs and academic institutions." Co-optation, anyone?

Edelman has made a name for itself outside of the pharmaceutical realm as well. A key chapter in Edelman's long and sordid history is their work on behalf of Big Tobacco. For example, in 1978, Edelman, working on behalf of R.J. Reynolds, produced a document titled Taking the Initiative on the Smoking Issue: A Total Program. The introduction states "The public mind-set against cigarettes is so firm that one cannot conscientiously promise miracles from the campaign suggested here. But we believe this program, executed effectively, can begin to slow or reverse the growing negative trends in public opinion regarding smoking; can stimulate a more balanced media coverage of smoking; and can generate a more congenial dialogue between smokers and non-smokers." In 1987, Edelman was tapped by INFOTAB, the international tobacco industry group made up of the major worldwide tobacco companies and their associated trade organizations, to work on a campaign to counter growing worldwide concerns about second-hand smoke. The product, a document titled "INFOTAB ETS Project: The Overall Plan," includes objectives like asserting that second-hand smoke is "just one (and a very minor) factor in a complex atmospheric mix which also includes petrol/diesel fumes, dust, bacteria, particles of dead skin, (particularly in air conditioned environments), solids of all kinds, pollen, and in industrial situations an enormous variety of chemical fumes and substances." Another aim is to "position the super-sensitive and vocal supporters of controls as an unrepresentative minority within a largely tolerant public -- a minority whose interests deserve care and consideration but should not be allowed to impose regulation upon the majority."

Edelman has consistently positioned itself as a PR firm that can successfully create partnerships between businesses and non-profits that will serve their corporate clients well. Two of their success stories are the Chiquita-Rainforest Alliance and Home Depot-Forest Stewardship Council relationship. Lest the full impact of their services not be appreciated by potential clients, Edelman spelled it out bluntly in a December, 2000, press release: "You've got an environmental disaster on your hands. Have you consulted with Greenpeace in developing your crisis response plan? Co-opting your would-be attackers may seem counter-intuitive, but it makes sense when you consider that NGOs (non-governmental organizations) are trusted by the public nearly two-to-one to 'do what's right' compared with government bodies, media organizations and corporations."

Edelman's work on the HPV campaigns has gained attention and adulation for itself and for Merck. The website of Pharmaceutical Executive Magazine published a lengthy and fawning article in February 2007, detailing why it selected Gardasil as its first annual Brand of the Year. "By combining innovative science, strategic commercialization, and savvy disease education, Team Gardasil created a campaign that evoked Merck in its prime -- and made strides toward stamping out cervical cancer." The article bluntly praises the manipulation of women and girls in Merck's campaigns. Author Beth Herskovits writes, "The disease awareness effort did more than just play on cancer fears, but drew on themes of safeguarding your children (for moms) and empowerment (for girls)." She goes on to quote Bev Lybrand, Merck's vice president and general manager for Gardasil. "Of course everyone understands cancer and is scared of cancer, but we learned early on that moms really wanted to protect their daughters -- that protective insight is important. For young women, they want to empower themselves to take control of their own destiny."

One of eight e-cards available at the "Tell Someone" campaign website.Merck and Edelman were also big winners at the May 3, 2007, PhAME Awards, which bill themselves as "the first and most comprehensive awards ceremony focusing on pharmaceutical consumer marketing and communications." Merck took home the Public Health Award, "presented annually to the consumer marketing advertisement that can demonstrate the most positive impact on patient/public health" for the "Tell Someone" campaign. Also recognized were two advertising agencies that worked on the project, DDB Worldwide and Rapp Collins. The "Tell Someone" campaign also won for Best Integrated Campaign, Best Multicultural Campaign, and Best Unbranded Ad. Merck also took home best Marketer of the Year.

In addition, Nancy Turett, Global President for Health at Edelman, was inducted into the prestigious Hall of PhAME, which "provides special recognition to individuals or teams who have demonstrated significant excellence in pharmaceutical marketing leadership and/or advancement of consumer marketing efforts over the past several years." In a September 2002, article in Pharmaceutical Executive Magazine entitled "Forging Alliances", Turett is quoted as asking, "So what does PR stand for? It stands for powerful relationships. The heart of PR is third-party credibility." She continued, "Third-party messages are an essential means of communication for validating scientific credibility, for legitimizing products, for building brand and disease awareness, and for building defenses against crises. As advocates develop louder voices, pharma companies must forge alliances and win allies."

So, What's the Harm? The Risks of Believing the Hype

Ironically, there is serious concern that vaccination may in fact create a false sense of security that will make reliable and effective Pap screening seem less important and cases of HPV infection that develop into cervical cancer more common. As with other cancers, the World Health Organization's (WHO)'s recommended approach to cervical cancer is comprehensive, "comprising prevention, early detection and screening, treatment and palliative care. The future addition of vaccine to the armoury in the fight against cervical cancer will be only one component of any successful strategy," says Dr Andreas Ullrich, Medical Officer Cancer Control at WHO's Department of Chronic Diseases and Health Promotion. Even with the promise of an effective vaccine, "There is no question that early detection will continue to be a key element even once a vaccine is available."

Merck is counting on word-of-mouth marketing by women to push the demand for GardasilMerck may try to say that their "education" campaigns are not about Gardasil specifically, but the result is obviously building interest in a quick-fix solution. Dr. Diane Harper is a professor at the Dartmouth Medical School, and has been studying HPV for almost 20 years. She was involved with both Merck and GlaxoSmithKline in drug trial design as well as a principal investigator at the clinic site for both the phase two and phase three trials for both Gardasil and its soon to be competitor, Cervarix. In our interview, I asked Dr. Harper if she is worried that vaccination and general misunderstanding could lead to reduced screening. "I think those are very valid concerns," she said. "I've heard it myself. You go through the grocery store aisles, to the beauty shop, to the local concert and if anyone's talking about the vaccine, what you hear is 'I think I’m going to get that vaccine because I won't have to get my Paps anymore.' I think the risk of that is really very high." Dr Harper used the case of Finland as an unfortunate illustration. Finland has long been the gold standard of effective cervical cancer screening programs -- they were close to 100% participation. But because the early screening and treatment were so effective and comprehensive, young women became lax in their participation. Because young Finns have never known someone who has had cervical cancer, the risk doesn't seem serious enough to motivate them to get a Pap test regularly.

Dr. Harper is speaking out publicly about her concerns because she first took them to Merck but they fell on intentionally deaf ears. It is not just women on the street that are prone to the misconceptions that concern Dr. Harper. A February 1, 2007, Hartford Courant article quotes a Connecticut state legislator, DebraLee Hovey, as saying during a debate about a state government vaccination mandate, "Any person who becomes aware that they can vaccinate their young daughter, and their daughters will never have to worry about cervical cancer, will want to have it." This illustrates perfectly the faulty logic that the PR juggernaut has promoted and that Merck is loathe to correct. Ms. Hovey is a member of Women In Government, the focus of the next article in this series.

While Dr. Harper is confident that the vaccine is good and will in fact help prevent some cases of cervical cancer, there are serious issues about the push to vaccinate 11 and 12 year old girls. "We shouldn't think about this as a 'virgin vaccine.' … This is a vaccine that will prevent disease in women of all ages. So the target, and the extreme emphasis on twelve-year olds, is misleading to the public in making them feel that this is a vaccine that you have to get before anyone ... has touched your genitals." Dr. Harper added, "We also have some evidence now that Gardasil is losing efficacy after five years. So if you need a booster shot later, are we really providing the best protection by vaccinating at an early age?" Efficacy could be declining before the girl even becomes sexually active, and if a booster is needed, but is not given, a woman might assume the first shot is giving her coverage when it is no longer effective.

While Merck and its partners have been working to reach individuals to convince them of their need for this vaccine, they have also been pursuing an even more fruitful goal. Merck's hope is that most if not all states will mandate a vaccine against HPV as a pre-requisite for school attendance. A mandatory vaccination for more than half of the population is the financial equivalent of the Holy Grail for a pharmaceutical company. Dr. Harper mentioned that GlaxoSmithKline's competing vaccine, Cervarix, is showing longer efficacy than Gardasil in the trials, but since it is not yet on the market, "the push, if there was a mandate, would mean that all the vaccine would be purchased from Merck because they are currently the sole provider. No one's thinking about what happens in five or ten years and who pays for the boosters. Or that all of the work that we've done to get to these people will have to be re-done at intervals throughout their life in order to keep the rate of cancer actually lower."

In the next article, "Women In Government: Merck's Trojan Horse," we'll look in detail at the campaign for state mandates of the vaccines and at Women in Government, the industry-funded non-profit that serves as the bridge between Merck and the legislators it needs to win over.