TEXAS TO REQUIRE POORLY TESTED VACCINE
[The tests on this vaccine have been mainly on older girls and women, have been short term and were sponsored by Merck]
RALPH BLUMENTHAL, NY TIMES - Texas on Friday became the first state to require all 11- and 12-year-old girls entering the sixth grade to be vaccinated against a sexually transmitted virus that causes cervical cancer.
GREGORY LOPES, WASHINGTON TIMES - The 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. . .
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. . .
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 of shots.
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. . .
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.". . .
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.