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Is HPV Vaccine Benefit Exaggerated?

Experts Debate Whether Gardasil Marketing Clouds Risk/Benefit Decision
By
WebMD Health News
Reviewed by Louise Chang, MD

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Aug. 18, 2009 – Merck's Gardasil won the Pharmaceutical Executive 2006 "brand of the year" award for "creating a market out of thin air." But is the HPV vaccine oversold?

The charge comes from a "special communication" and an editorial in the Aug. 19 issue of TheJournal of the American Medical Association.

The articles say professional medical associations worked with Merck to overstate the vaccine's ability to prevent cervical cancer -- even before studies proved Gardasil can prevent precancerous cervical lesions.

Overselling the HPV vaccine's benefits makes it impossible for parents and young women to judge whether the vaccine's risks are worth taking, says editorialist Charlotte Haug, MD, PhD, editor-in-chief of the Journal of the Norwegian Medical Association.

"If it were a perfect vaccine you would never have to think about cervical cancer again. But it is effective against two of the strains of the virus, and there are at least 20 cancer-causing strains out there," Haug tells WebMD. "It is true these strains cause 70% of cervical cancers, but what happens when we take these two strains away? If you kill the weeds in your lawn, there will not always be a hole there. Something will take their place."

Just because we don't know this doesn't mean the vaccine isn't valuable, says Janet Englund, MD, an infectious disease pediatrician at Seattle Children's Hospital. Englund chairs the HPV Working Group of the CDC's Advisory Committee on Immunization Practices (ACIP).

"It is true we don't know for sure about the vaccine's long-term ability to prevent high-grade cancer," Englund tells WebMD. "My assessment, my personal viewpoint, is there is very good evidence for both reduction of [precancerous] cervical intraepithelial neoplasia -- it is really clear -- and that there is reduction of genital warts."

For Englund, it's not merely an abstract opinion.

"I have vaccinated my children," she says. "I take the risks and benefits into consideration, and I think the benefits outweigh the risks."

HPV, human papillomavirus, is a very common sexually transmitted infection. Most sexually active women and men get the virus -- often more than once, and often with more than one strain. Usually, the immune system clears the virus. But sometimes it sticks around. Some strains of the virus cause genital warts. Other strains cause cancer.

Gardasil protects against four of the more than 100 strains of HPV: the two strains that cause most cervical cancers, and two strains linked to genital warts. The vaccine is most effective if given to girls before they become sexually active. It can be given as early as age 9; the CDC recommends it for 11- and 12-year-old girls. The vaccine costs $300 to $500, but is covered by the U.S. Vaccines For Children program.

Gardasil Oversold by Medical Groups?

Columbia University researchers Sheila Rothman, PhD, and David Rothman, PhD, suggest that at least three medical associations used funds and other assistance from Merck to create educational materials for non-specialist doctors that promoted Gardasil.

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