PR challenges await as FDA is set to vote on Merck's Gardasil

The FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended the approval of a cancer vaccine on May 18. The drug, Gardasil, which is manufactured by Merck, will fight against four strands of the human papilloma virus (HPV) that has been linked to cervical cancer.

The FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended the approval of a cancer vaccine on May 18. The drug, Gardasil, which is manufactured by Merck, will fight against four strands of the human papilloma virus (HPV) that has been linked to cervical cancer.

Gardasil is the first vaccine to fight cancer. The FDA is set to vote on approval on June 8. Although not required to take the advisory panel's recommendation, the FDA usually does.

The drug is meant for women who are not yet sexually active. If approved, another panel will decide who receives the vaccine. GlaxoSmithKline is also developing a cervical cancer drug, Cervarix, which has not yet been sent for FDA approval.

Why does it matter?

"It's challenging because the social issues can trump the science," says Megan Svensen, EVP, healthcare at Marina Maher Communications. "They must look at addressing social concerns. Merck is doing this by making the connection between HPV and cervical cancer so that this becomes more of a story about cancer and less about sexually transmitted diseases."

Svensen adds that building support within advocacy groups, such as women's health advocates and cancer-advocate organizations, was very important to the success of marketing a product that that can be socially volatile. "I think there are people out there who will not agree with this vaccine, regardless of what you say to them about it," she notes.

Five facts:

1 According to the University of Alabama-Birmingham, more than 450,000 women are diagnosed with cervical cancer each year and almost half of those women die from the disease. In the US, approximately 12,000 women are diagnosed with cervical cancer, resulting in 4,500 deaths each year.

2 HPV is a common sexually transmitted virus. Most people who have ever had sex have been infected. Yet, most don't ever know because it does not cause any symptoms and it is easily extinguished by the immune system.

3 Merck is trying to push the availability of the vaccine to kids as young as 9. Merck is looking to have Gardasil as part of the vaccine requirement for school entry.

4 Merck already faces opposition from the Christian Right. The evangelical Christian group Focus on the Family and the Family Research Center have both expressed concern about the promotion of promiscuity in teens due to a vaccine that would leave them with less risk of contracting a disease.

5 Merck has been touting Gardasil as its next big product and is already running ads about HPV. Merck has seen troubled times with the lawsuits regarding Vioxx and the patent-end of money-maker Zocor coming up in June.

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