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leftchick Donating Member (1000+ posts) Send PM | Profile | Ignore Tue Jul-03-07 04:50 PM
Response to Reply #7
8. and more reasons here...

Some critics pointed out that the test period was too short to assess long-term effects and efficacy. In fact, the studies on children, who often react differently to drugs, were shorter yet, and smaller. Only 1,184 subjects in the nine to 15 year-old age test group got Gardasil, and they were followed for 18 months, according to New Scientist magazine. A Merck spokesperson refused to break down the data further to reveal how many of that small sample were below the age of puberty.

And then there is the possibility that, given time and real-world conditions, side effects will emerge. FDA briefing papers noted a small increase in birth defects in the babies of women given the vaccine within 30 days of becoming pregnant over those who took a placebo. The number, while not establishing causality, triggered an FDA recommendation that pregnant women not be vaccinated. The background documents also raised questions about whether selectively targeting a few HPV viruses (there are more than 100) would "advantage others." Another concern "was the potential for Gardasil to enhance disease among" subjects already infected "with vaccine-relevant HPV."

These kinds of concerns are not necessarily alarming or unusual for a new drug, According to a 2002 study in the Journal of the American Medical Association, "The safety of new agents cannot be known with certainty until a drug has been on the market for years. Serious ADRs commonly emerge after Food and Drug Administration approval."

"The published data look great, but at the very least, I would like to see efficacy data among 11 and 12 years old, which won't emerge until they are sexually active," says Karen Smith-McCune, a University of California associate professor of obstetrics and gynecology.
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