Since the FDA's VAERS is known to catch perhaps 10% of adverse events at best, according to a 2004 report in the New England Journal of Medicine by the FDA, the actual numbers may be far higher.
It is difficult to prove whether the vaccine was the culprit behind these side effects -- just because two events happen, it does not mean that one caused the other, says Dr. Laurie E. Markowitz, an epidemiologist at the CDC who has had her own daughter vaccinated. The deaths, and all the other serious events, could have happened in the absence of the vaccine, she says.
Markowitz remains convinced the vaccine is safe. "The CDC and the FDA checked out these reports very carefully," she says. "And we've done calculations for the number of cases reported and the number of cases that you'd find in the general population, and we have not found an increase."
Given these caveats, should girls be getting the shots?
Most major medical groups still think Gardasil should be part of routine immunizations for 11- and 12-year-old girls.
Shots still strongly urged
There is more than the matter of cancer prevention, says Dr. Joseph A. Bocchini, chief of pediatric infectious disease at Louisiana State University Health Sciences Center in Shreveport and chairman of the American Academy of Pediatrics committee on infectious diseases. The vaccine could spare hundreds of thousands of women from the psychological trauma and physical pain of a cycle of follow-up tests when they have an abnormal Pap test result and the treatments for pre-cancerous lesions that can cause infertility.
"You can actually prevent these infections and the cervical abnormalities that require more invasive interventions," he says.
Whether the shots should be mandatory -- a step that has been considered by Texas, Michigan and Virginia -- is another issue. "This decision should be up to parents, and mandates are silly," says Harper of Dartmouth. "While the vaccine will improve the health of American women, its real benefit is in the developing world. And no matter what, Pap screening shouldn't be neglected. That's still our best safety net."
--
health@latimes.com
