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
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