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Is HPV Vaccine Benefit Exaggerated?

Experts Debate Whether Gardasil Marketing Clouds Risk/Benefit Decision

Gardasil Oversold by Medical Groups? continued...

"Doctors may not know that this education is not being done by a group of experts in the field but that it is all being orchestrated by the drug company," Sheila Rothman tells WebMD.

Stewart Massad, MD, ethics chair for the American Society for Colposcopy and Cervical Pathology -- one of the groups named by the Rothmans -- says that although the Rothmans are right that his group supports HPV vaccination, they are wrong to say Merck wrote their educational materials.

"HPV vaccine is a revolutionary advance that promises to change the way cervical cancer is prevented," Massad tells WebMD. "We thought our members needed to know about it. We sought funding from elsewhere, but we were not able to find nonprofit or government funding to fill the costs. We disclosed Merck's support in all the materials we distributed, and Merck had no role in writing them. They signed off on the concept but were not allowed to have any input on material that was developed."

The Society of Gynecologic Oncologists said in a statement provided to WebMD that its materials are unbiased. The third group named by the Rothmans, the American College Health Association, did not respond to WebMD's request for comment.

But the Rothmans' article suggests that these medical associations overemphasized the risk posed by HPV and overstated the scientific evidence supporting Gardasil's ability to prevent cancer.

"The fact is that most of the HPV infections are symptomless; most of it goes away by itself," Rothman says. "Only 10% of infections go on to become lesions. Yes, we have causative agent and a disease. But it is not a straight line to get there. And what the company did was create a straight line and get the organizations to go along with it and legitimize it."

Richard M. Haupt, MD, MPH, Merck's executive director of clinical research, says Rothman is wrong.

"There is very good evidence regarding the line leading from HPV infection to cancer," Haupt tells WebMD. "If you don't get infection with these cancer-causing strains of HPV, you don't get cervical cancer."

Massad says the line between HPV infection and cervical cancer may be blurry -- but it's a line all the same.

"Most women who get HPV are never at risk for cervical cancer -- but we don't have a way to tell who is and who is not at risk," Massad says. "It seems better to do widespread vaccination than not to take any action all."

Haug says such an approach ignores the cost of the vaccine, and the risk of vaccination to women who might never get cervical cancer.

HPV Vaccine, Pap Screens, and Cervical Cancer

Rothman notes that whether or not women receive the vaccine, they still need regular Pap screening to look for early signs of cervical cancer. Screening cuts their risk of cervical cancer, and thus cuts the benefit of HPV vaccination.

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