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Gardasil Could Be Effective, but Aggressive Marketing Raises Ethical Concerns

Mercks Gardasil does show real promise for reducing HPV infection in women. Given the increasingly permissive ways of the West , the human papilloma virus is a looming danger and one has to go all out to fight cervical cancer.

But the multi-million marketing by the multi-national drug manufacturer has made experts uneasy.

To give the impression that it could completely eliminate cervical cancer is quite misleading, they say.

Merck used their deep pockets to make sure that even before the FDA had approved Gardasil, The marketing juggernaut was multifaceted and meticulously planned. In 2005 Merck started by funding a campaign called "Make the Connection," run by avowed non-governmental organizations.

A key element of the campaign is the Make the Connection bead, part of a create-it-yourself bracelet kit that will help raise cervical cancer awareness. Make the Connection bracelet kits are available free through the campaign's Web site and toll-free information line and 888-4-HPV-CONNECT -and also at Make the Connection beading events across the country. Everyone who orders the free Make the Connection bracelet kit will get two kits, so she can invite someone to join her in showing support against cervical cancer. The beading events will bring women together to bead, talk about cervical cancer and meet the young actresses who are part of the campaign:, so gushed a website.

It is estimated 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." Funded by Merck, "Make the Commitment" nudged women along the path of demanding Gardasil when it would be FDA approved and available.

At the "Make the Commitment" website, women are challenged to sign the following pledge:

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

This pledge to talk with their doctors about cervical cancer would ensure that medical practitioners were virtually pressured from all sides -- from Merck's drug reps, from patients, and with any luck, by state legislators.

It was also affirmed that for each commitment made, Merck would donate one dollar to CRPF, up to $100,000, for cervical cancer awareness and screening programs.

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 been suspicious of the motivations of a pharmaceutical company, notes Judith Siers-Poisson.

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 Food and Drug Administration (FDA) approved Gardasil.

But advertising for Gardasil did not slow down. Now the message was - "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 appliquing "one less" on the front of a hoodie, "hooded sweatshirt", is a heavy upper-body garment with a hood. Young girls jumping rope at the end chant "I want to be one less, one less! O-N-E-L-E-S-S!"

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.

Apparently Merck is hoping that most, if not all the states in the US, will mandate a vaccine against HPV as a pre-requisite for school attendance. And beat rival to it, before GlaxoSmithKline gets FDA approval for its Cervarix.

For all the hype, 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."

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 Cervarix.

She shares the concern of many that the hype could lead to reduced screening. "I think those are very valid concerns," she said. "I've heard it myself. You go through t he 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."

The Pap test, also called the Pap smear, is a cervical cancer screening test. It is not used to detect other kinds of cancer. It is done in a doctor's office or a clinic. This test can find abnormal cells in the cervix that may turn into cancer if they're not treated.

During the test, the doctor or nurse uses a plastic or metal instrument, called a speculum, to widen the vagina. This helps the doctor or nurse examine the vagina and the cervix, and collect a few cells and mucus from the cervix and the area around it. These cells are placed on a slide and sent to a laboratory to be checked for abnormal cells.

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, any more.

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 adds, "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, Harper points out.

SOURCE The Politics and PR of Cervical Cancer

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