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Gardasil's Marketing Raises Ethical Issues

Susannah Snider |
January 11, 2010 | 6:57 a.m. PST

Contributor
HPVaccine_f
HPVaccine_f

Pharmaceutical company Merck's marketing techniques earned HPV vaccine
Gardasil a "pharmaceutical brand of the year" award for its "savvy disease
education" and building "a market out of thin air."

In 1999, Susie Carillo was diagnosed with the human papillomavirus, a sexually transmitted infection that can cause cancer. The young mother didn't understand what it was. "I didn't know the seriousness of it. There was no information," said Carillo, who was pregnant with her first child when her doctor noticed the infection. "I didn't ask any questions, I just put it away."

For Carillo, 30, living with HPV has been difficult physically and emotionally. Unlike 90 percent of cases, where the immune system quickly clears the virus, Carillo's HPV didn't disappear. Instead, Carillo, an office manager, underwent a cone biopsy, the removal of tissue from the cervix, which left her on bed rest for several weeks.

Returning home wasn't any easier. Her husband blamed Carillo for the infection and she felt ashamed. Carillo eventually filed for divorce. "I'm still figuring out what I went through. It's a learning experience for me now," Carillo said. "My experience was horrible because I had to go through it alone."

A decade later, Carillo's situation seems unimaginable. Since then, information about HPV has flooded television screens, movie screens, and computer screens. Doctors stack HPV pamphlets in their offices and moviegoers may remember a 60-second commercial about an HPV vaccine before the Sex and the City movie in 2008.

So, what changed?

Gardasil.

The FDA approved a vaccine against HPV in 2006 called Gardasil. To inform Americans about the vaccine, pharmaceutical company Merck launched an aggressive advertising campaign.

The promotion was successful. Merck's marketing techniques even earned Gardasil a "pharmaceutical brand of the year" award from Pharmaceutical Executive for its "savvy disease education," and building "a market out of thin air."

Today, Gardasil is Merck's best-selling vaccine. It brought in $1.4 billion in 2008, according to Merck's annual 10K form.

But Merck's marketing strategy has been anything but transparent. Instead, it has dominated the conversation about Gardasil, enlisting physicians and health care givers as covert spokespeople, glossing over difficult information, and allowing their bottom line to dictate the educational talking points.

In order to make the vaccine, which costs about $360 for 3 shots, palatable to American consumers, Merck took attention away from its unsavory qualities. The company marketed Gardasil as a cervical cancer vaccine, with girls in advertisements repeating the "one less" mantra--"one less woman who will battle cervical cancer."

Marketing Gardasil as a cervical cancer vaccine was cleverly misleading.

In fact, Gardasil is a sexually transmitted disease vaccine. Doctor Martin Kast, a professor of molecular microbiology and immunology, and obstetrics and gynecology at the University of Southern California, pointed out that cervical cancer is "indirectly an STD." Studies conducted on nuns and women with no sexual experience show that they almost never contract cervical cancer.

"It deals with a conservative country," Kast explained, about why Gardasil advertisements focus on cervical cancer instead of HPV. "It's an easier sell for a company to not bring up the STD issue."

The Pharmaceutical Executive marketing award noted that "Merck has had to negotiate a minefield of sensitivities related to the fact that because the human papillomavirus (HPV) is primarily transmitted through sexual contact, girls and young women ideally need to get the vaccine while they are still virgins."

There's no doubt that good can come from vaccines, some of which have obliterated terrible illnesses. Since the 1930s, "herd immunizations" have virtually wiped diseases, such as smallpox, diphtheria, and polio in America.

But dangers crop up when Gardasil's promises to stomp out cervical cancer by immunizing everyone.

An August 2009 article co-authored by Sheila and David Rothman, called "Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism," explained, "This campaign, which "circumvent [s] possible parental and public unease" can have a negative effect.

The piece, which was published in the Journal of the American Medical Association, argued that Gardasil's campaign "meant that rather than concentrating on populations in geographic areas with excess cervical cancer mortality...the marketing posited that every girl was at equal risk."

Gardasil's strategy doesn't target the neediest groups, such as Latinas along the Mexican border or African Americans in the South, but the most willing to pay.

In order to get across this message--that every woman should be vaccinated against cervical cancer--Gardasil couldn't just rely on television spots. The company launched a massive educational process that targeted doctors and health care givers.

The Rothmans' article points out that several organizations were handed grants to educate doctors about the Gardasil vaccine. Their funding wasn't consistently mentioned in the promotional materials, giving the false sense that the organizations independently supported Gardasil.

"I think what happened here was that marketing and medical education got blurred," Sheila Rothman, a professor at Columbia University's Mailman School of Public Health, told the Washington Post in August.

The Rothmans' article described a "Speaker Lecture Kit," which the American Society for Colposcopy and Cervical Pathology (and recipients of a $300,000 check from Merck) used to educate doctors about Gardasil. The kit is little more than Merck propaganda with a bottom line that says that almost every woman needs Gardasil.

For those who think they are too old to qualify, the kits suggest explaining that women are getting married later in life these days.

For women who hesitate to vaccinate their middle school-aged daughter, the materials recommend reminding mothers that girls are having sex earlier these days.

For boys, who aren't at risk for cervical cancer? Gardasil will get to that.

In September 2009, the FDA approved Gardasil for boys. The vaccine will protect against genital warts and less common cancers, such as anal and penile cancer. In addition, it will limit the chance that men will spread HPV to their partners.

Kast, who supports this move and even had his son vaccinated off-label, predicts that this will change the marketing strategy. "Merck has marketed [Gardasil] as a cervical cancer vaccine," Kast said. "If a boy doesn't have a cervix, why would he need a cervical cancer vaccine? I think the ads will change."

The idea of marketing Gardasil as a cervical cancer vaccine has another danger. Understanding how Gardasil works will help recipients realize that it is not a foolproof protection against cervical cancer.

Gardasil protects against four of about 40 types of HPV, according to the CDC's informational brochure. Two of these strains cause about 70 percent of cervical cancer; the other two lead to about 90 percent, according to the same brochure.

These odds are pretty good but don't cover 100 percent of cancer-causing HPV. Women should continue regular Pap tests and cancer screenings, even after receiving the vaccination.

A false sense of security could prevent them from receiving the appropriate post-vaccination care. It's easier to say "one less woman who will battle cervical cancer" than to repeat the more complex truth.

When the pharmaceutical companies, who have a bottom line to maintain, are the ones who control the discussion about a new medication, we need to change how we view it. When almost all information, from brochures in the doctor's office to the doctor's words of advice are canned promotional material, how can consumers make informed decisions about their own bodies?

How can we make sure that the marketers don't dominate the conversation about Gardasil?

"You don't just accept what is given to you," Kast recommended. "You explore what the companies are saying."

Donna Beard Gilchrist, a women's health nurse practitioner who counsels students about Gardasil at USC, recommends trusting the doctors and nurses who think for themselves. "People think we're taking what they [the pharmaceutical companies] say as the gospel truth," Beard said. "I'd like to think I can't be bought."

And if you decide that the vaccine isn't right for you, there are ways to limit the chance that you'll contract cervical cancer.

"Abstinence is number one - not very practical though," Kast suggested.

He also recommended using a condom (although it doesn't fully protect against the virus) and engaging with fewer sexual partners.

"Be religious about screenings," Gilchrist recommended to women who opt out of the vaccine.

Merck representatives would not grant this publication an interview.

As awareness increases about HPV, Americans are wizening up to the fact that independent support needs to exist. Groups like the HPV Awareness and Research Project (HARP), which Kast sponsors, is serving to work as an independent voice in the conversation about HPV. HARP has taken roots with Shauna Crahan, 26, a tutor during the day and an activist in her free time.

Crahan, a friendly blond, has a knack for helping people open up about the awkward subject of sexually transmitted infections. "People have been coming to me with their diagnoses since high school," said Crahan, who supports getting the Gardasil vaccine. "We can't expect doctors and nurses to be our only form of education."

As support groups such as HARP become established, the struggles of Carillo, the young office manager, will become increasingly rare. Carillo found Crahan through Facebook and is learning to speak up about her battles with HPV.

Her advice for women in her situation is simple: "Get all the information you can, ask questions and have a good support group going. Just don't be ashamed to ask questions."



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