By Gregory Lopes
THE WASHINGTON TIMES
Published February 3,
National Vaccine Information Center yesterday warned state officials to
investigate the safety of a breakthrough cancer vaccine as Texas became the
first state to make the vaccine mandatory for school-age girls.
Negative side effects of Gardasil, a new Merck vaccine to prevent the
sexually transmitted virus that causes cervical cancer, are being reported
in the District of Columbia and 20 states, including Virginia. The reactions
range from loss of consciousness to seizures.
"Young girls are experiencing severe headaches, dizziness, temporary
loss of vision and some girls have lost consciousness during what appear to
be seizures," said Vicky Debold, health policy analyst for the National
Vaccine Information Center, a nonprofit watchdog organization that was
created in the early 1980s to prevent vaccine injuries.
Following federal approval of the vaccine in July 2006, a storm of
legislation was introduced across the nation that would make the vaccine
mandatory in schools. The District and Virginia are part of a group of at
least 17 states considering such legislation. A measure had been introduced
in Maryland, but it was shelved last week over concerns about the mandatory
language in the bill.
Yesterday, Texas Gov. Rick Perry signed an order making Texas the first
state to require the vaccine. Girls ages 11 and 12 would receive the human
papillomavirus (HPV) vaccine before entering the sixth grade starting in
The American Cancer Society estimates there were 9,710 new cases of
cervical cancer in the United States in 2006. The District's cancer control
center estimates a total of cervical cancer cases in the city last year, and
the American Cancer Society estimates that last year Maryland and Virginia
each had 210 cases of cervical center.
Merck began marketing Gardasil last year after the Food and Drug
Administration approved it for females ages 9 to 26. The vaccine is the
first of its kind to build immunity against two strains of HPV, which lead
to 70 percent of cervical cancer cases in the United States.
The vaccine is not effective in men, who can get cancer from other
strains of HPV.
Its side effects were reported to the Vaccine Adverse Event Reporting
System, a federal reporting system for consumers to notify federal
regulators of bad reactions to medications. The adverse events began being
reported in July 2006, when an advisory panel to the Centers for Disease
Control and Prevention recommended girls ages 11 and 12 receive the series
The types of side effects reported are not cause for alarm, according to
the American Cancer Society.
"We have not been informed of an instance that would call into question
the overall safety of the vaccine," said Debbie Saslow, director of breast
and cervical cancer control at the American Cancer Society, adding that
about 70 similar events had been known in October 2006.
Likewise, the CDC will not alter its approval of the vaccine despite the
number of adverse events revealed through the reporting system.
"A report to the Vaccine Adverse Event Reporting System does not
necessarily mean the adverse event was serious or that it was caused by the
vaccine," said CDC spokesman Curtis Allen. "This vaccine has been tested
around the world and has been found to be safe and effective."
Merck is heavily promoting the vaccine through its salespeople imploring
doctors to provide it and running TV ads urging young women to get
vaccinated so there will be "One Less" cancer patient.
But physicians disagree with public health officials over whether
Gardasil is the panacea for cancer. Clayton Young, an
obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil
will prevent cervical cancer.
"There is no proof Gardasil will stop cervical cancer," he said. "They
haven't been studying it long enough to make that claim."
Merck spokesman Chris Loder said the vaccine is effective for five years
and the Whitehouse Station, N.J., drug maker is not sure how long afterward
the vaccine will work. Critics point out that an additional booster shot may
be necessary. Advocates for a mandatory vaccine say that although the
vaccine does not prevent all causes of cervical cancer, Gardasil is an
effective vaccine against the most prevalent cause and therefore is a
correct public health measure.
Gardasil is delivered in three separate injections that cost $120 to
$150 per injection. Blue Cross Blue Shield, an omnipresent health insurer in
the Mid-Atlantic region, covers the vaccine for girls in the federally
recommended age groups.
Merck revenue from Gardasil reached $155 million for the fourth quarter
of 2006 and $255 million for the entire year.
Further Reading: NVIC Statement on Dangers