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Gardasil Side Effects: Should Women Get It?
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by candice.tsuei | August 19, 2009 at 09:12 am
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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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candice.tsuei
Vancouver, British Columbia, Canada
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at 09:40 on August 19th, 2009
6.2% is better odds than you'll get in Vegas- If I were a parent, I'd not give this to my kid.
at 10:04 on September 29th, 2009
That sentence in tremendously misleading -- 6.2% of subjects WHO HAD ADVERSE REACTIONS had serious ones. The real number is 0.003% from the numbers right in this article.- The 12,424 overall adverse reactions (which included fainting, and presumably soreness and fever, since those are the major reactions reported) were out of 23 million (23,000,000) doses, or 0.05% reactions to total doses.- The 772 serious side effects (the supposed "6.2%") represent 0.003% of the doses, while the 32 deaths are 0.0001%.In contrast, HPV infections have much higher prevalence rates, and the risk of dying from cervical cancer is several orders of magnitude larger.- HPV infections are very common (as much as 25 to 30% of the population at any time, although most infections clear by themselves and only the two strains most related to cancer are preventable with this vaccine).- In the U.S. and Canada, about 0.3% of the entire female population has what may be pre-cancerous changes to the cervix found EACH YEAR. Also each year, 0.007% of the population develop cervical cancer, and 0.002% die.The two HPV strains covered by the vaccine are the major cause of cervical cancer -- a discovery that led to a Nobel Prize for the researcher who figured that out, and which prompted the development of the vaccines in the first place.Right now, between 8% and 27% of women diagnosed with cervical cancer die from it, depending on how early it is detected using Pap tests and similar screening.So by my rough calculation above, women are at least 20 times (2000%!) more likely to die from cervical cancer than from any side effects of the vaccine designed to prevent it.
at 10:40 on October 5th, 2009
Gee, you wouldn't work for Merck now, would you?
at 19:11 on October 9th, 2009
Before anyone gives a big sigh of relief, the "Analysis by the NVIC of Gardasil & Menactra Adverse Event Reports to the Vaccine Adverse Events Reporting System (VAERS)" dated February, 2009, includes information that "It is estimated that only between 1 and 10 percent of all adverse health outcomes which occur following vaccination are reported to VAERS." This would automatically multiply those adverse reaction numbers by a factor of 10 or more.
If you'll look at the list of serious adverse reactions reported through 2007 on page 2 of the Analysis, you'll see that nearly half the reactions required a trip to the Emergency Room and about 20% of those girls "Did Not Recover." These risks are NOT acceptable when the HPV they are trying to prevent is so avoidable and cervical cancer is so detectable & highly cureable!