Aug. 18, 2009
Is the HPV Vaccine Safe?
First Major Study Released on Vaccine's Side Effects, Plus a Review of
Merck's Marketing Tactics
(CBS) When Barbara Archiello's doctor recommended a vaccine to prevent
cancer of the cervix, she jumped at the chance.
"I think it's just a great thing for women to have," Archiello said.
But the most comprehensive look at the side-effects of since the HPV vaccine was
approved in 2006 raises questions about its safety, reports CBS News medical
correspondent Dr. Jon LaPook.
In Tuesday's Journal of the American Medical Association, the CDC reported more
than 12,000 side effects after 23 million doses were distributed. Ninety-four
percent of the problems were not serious but 6 percent were, including patients
who were hospitalized, permanently disabled or died. There were 32 deaths - one
in over 700,000 doses.
"It really isn't an increase with what we've seen with other vaccines and what
is seen regularly with people of that age group," said Dr. Barbara Slade, with
But problems that did occur more frequently than expected were fainting - about
once every 12,000 doses, and blood clots, once every 500,000 doses.
"The reporting on blood clots was concerning to CDC, concerning in the way that
we think it needs further investigation," Slade said.
Critics question the vaccine maker's aggressive ad campaign, because it paid
medical societies to help spread the word, and underplayed the importance of
evaluating the vaccine's risks and benefits.
"It screeched the message, 'all women are at equal risk, protect yourself from
cervical cancer, and this is the way to do it,'" said Dr. Sheila Rothman, author
of the JAMA article. "The fact that the medical societies repeated this message
is what concerns us."
Merck says after reviewing the new report of adverse events, it continues to be
confident in the safety of the vaccine. While the CDC and FDA continue to
recommend its use, doctors say they'll look at the HPV vaccine for girls and
women on a case-by-case basis.
"If you're going to administer the vaccine, you should discuss these risks with
your patient and do a risk assessment." Said Dr. Daniel Smith, with Hackensack
University's Medical School.
Something else to consider for parents uncertain about whether to have their
daughters vaccinated - Routine pap smears can also help prevent cervical cancer.