Gardasil Side Effects: Should Women Get It?
There has been heated controversy about Gardasil, which is a Merck & Co.'s revolutionary vaccine designed to prevent certain infections with human papillomavirus (HPV), mainly cervical cancer and genital warts, because of the side effects that come with it.
Published in today's edition of the Journal of the American Medical Association, a study shows that of the 23 million doses of Gardasil administered to young women since it came on the market on June 1, 2006 to December 31, 2008, 12,424 adverse reactions have been reported.
For every 100,000 shots, eight women will faint, seven will have skin reactions at the injection site, and seven will become dizzy, according to a study conducted by the Centers for Disease Control and Prevention in Atlanta.
The data also show that 6.2%, or 772 of the young women, experienced serious side effects after taking the Gardasil vaccine, including anaphylaxis, a lethal allergic reaction, blood clots, pancreatic failure, and otor neuron disease. There have also been 32 reports of death, and only 20 of the deaths could be verified, as the others were either provided by Merck & Co. without further information or unverifiable secondhand reports.
Despite the figures, the tone of the study was reassuring.
“We feel confident recommending people get the vaccine; the benefits still outweigh the risks,” said Dr. Barbara A. Slade, the study’s first author and medical officer with the Centers for Disease Control and Prevention, which did the study together with the Food and Drug Administration. She added, “This is the most complete picture we have.”
Now there is another side of the controversy: when inoculating a healthy population against a disease that can be prevented through screening, is any level of risk acceptable?
“There are not a huge number of side effects here, that’s fairly certain,” said the editorial writer, Dr. Charlotte Haug, an infectious disease expert from Norway, about the vaccine. “But you are giving this to perfectly healthy young girls, so even a rare thing may be too much of a risk.
“I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” Dr. Haug said in an interview. “You don’t have to die from cervical cancer if you have access to health care.”
There have also been criticisms around the marketing scheme of Gardasil. In a separate article in the journal, two researchers criticized Merck & Co. for not distributing the vaccine equally and avoiding women with limited access to health care, who were most at risk of developing cervical cancer.
Currently, Gardasil is approved by the U.S. Food and Drug Administration for females ages 9 to 26. In Canada, there are no comparabledata, and Health Canada's adverse drug reaction database has no entries for Gardasil.
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Vancouver, British Columbia, Canada