Posted on 12/06/2007 11:02:05 AM PST by Pyro7480
Since June 2006, when the HPV vaccine Gardasil was approved by the Food and Drug Administration, there have been 28 reported cases in which pregnant women miscarried after receiving the vaccine.
Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women.
In May, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy."
In July, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn't been determined, according to a report.
The reasons for two other miscarriages this year in Florida - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages.
Gardasil is the vaccine to prevent the Human Papillomavirus (HPV), a sexually transmitted disease and the leading cause of cervical cancer in women. The package insert for Gardasil states there is "no evidence" the vaccine will cause "impaired female fertility or harm the fetus."
Most of the 28 reports of miscarriage, which were drawn from the Vaccine Adverse Event Reporting System (VAERS), were attributed to "other medical event." VAERS reports contain raw, unanalyzed data sent by concerned parties to the FDA and the U.S. Centers for Disease Control and Prevention.
The only Gardasil side effect the FDA has expressed concern about is dizziness immediately after the shot, FDA spokeswoman Karen Riley said. "We've not seen signals" of a disproportionate problem with Gardasil and pregnant women, she said.
"If you're pregnant, then it means you've been sexually active," Riley said. "So it would be somewhat dubious to get a vaccine you're supposed to have before you're sexually active."
While there is no conclusive evidence that any health problems have been caused by the vaccine, Judicial Watch, the conservative government watchdog group that obtained the VAERS reports through a lawsuit, is concerned that the FDA is not scrutinizing the vaccine more closely.
Judicial Watch President Tom Fitton said his group wants to know more about the FDA's approval of Gardasil and monitoring of potential problems with the vaccine, which some states either have or are considering mandating for school girls.
"Merck lobbied for these mandates," Fitton told Cybercast News Service . "There are moral issues here. But the primary issue is public health and safety. It's interesting why our government downplays the apparent adverse reactions of Gardasil. Why are drugs with a distinct social agenda getting less scrutiny in the approval process?"
Riley stressed that the numbers concerning the pregnancies must be placed in context.
"Have they (Judicial Watch) compared that to a similar group of young pregnant women of the same age group who haven't had Gardasil?" Riley said. "There is always a certain percentage of children born with abnormalities among any sampling. The only way to say if there is a causality relationship is to compare one group to see if they have a higher rate than another group."
A total of 3,461 adverse reactions, including eight deaths, were reported to the government through the VAERS system since the FDA approved the drug.
Reproduction studies were conducted on female rats at doses up to 300 times the human dose, according to Merck. The tests on the lab rats showed no adverse effect on reproduction or pregnancy. However, the company literature on Gardasil said, "It is not known whether Gardasil should be given to pregnant women."
During Merck's clinical trials of 2,226 women, half got the Gardasil vaccine, and the other half got a placebo or empty vaccine. In that group, 40 on Gardasil and 41 on the placebo had an adverse event in their pregnancy.
The most common adverse events were conditions that can result in cesarean section or premature labor. The portions between the Gardasil and placebo were comparable, Merck said.
Merck spokeswoman Jennifer Allen said 2 to 3 percent of the women who became pregnant during the clinical trials had children with problems, and roughly 15 percent of those had miscarriages. This, she said, mirrors the general public of pregnant women, regardless of whether they had the vaccine.
Pointing to the fact that VAERS reports are raw data, she said there was little reason to believe a causal relationship existed.
"It's what you see in the database of the general population," Allen told Cybercast News Service . "VAERS are passive reports. It's plausible someone would get the vaccine, leave the doctor's office and walk into a pole. You could report that and VAERS would accept it."
Much of the controversy surrounding Gardasil pertains to the fact that three states - Massachusetts, New Jersey, and Virginia - are mandating sixth-grade girls get the vaccine, and other states are considering such a mandate.
The three states included an opt-out provision, which would let parents choose not to have the vaccine administered to their child for religious or other reasons.
Meanwhile, 38 other states this year passed or considered some type of legislation either mandating, funding, or educating the public about the vaccine, according to the National Council of State Legislatures. New Hampshire and Alaska adopted a voluntary program that supplies the vaccine for free to girls between ages 11 and 18 who want it.
Meanwhile, abroad, the British Department of Health approved a national mandate for school girls to get the vaccine.
After the FDA approved Gardasil, the Advisory Committee on Immunization Practices recommended routine vaccinations for girls ages 11 and 12. HPV infects 20 million people in the United States, with about 6.2 million new cases each year, according to the Centers for Disease Control and Prevention. HPV is responsible for nearly 70 percent of cervical cancer cases.
The American College of Pediatrics and the New England Journal of Medicine have voiced opposition to mandating the vaccine.
“My problem with this is the push to mandate it. Diseases like smallpox, chicken pox, measles, mumps, polio, etc. spread through everyday contact between children. Short of a vaccine, there is no certain way to avoid catching them, this is simply not the case with an STD.”
I agree with you.
If we stopped screening this rare disease would quickly become common. I have no confidence that simply telling people to behave better will have any effect. Our realistic options are screenig, vaccination or a five-fold increase in cervical cancer deaths.
Most of those women didn't have regular Paps. Odds are they wouldn't get the vaccine either.
It would be if it worked, even though “filling them full of drugs” as you put it doesn’t seem to be endangering them either.
Autism, ADHD, cancers of all types.......yeah. Kids are a lot healthier now. And no, I'm not against all vaccines. But we need to be more careful in what we casually give kids.
Frequently Asked Questions about Cancer, Simian Virus 40 (SV40), and Polio Vaccine
I guess those who screw up and catch HPV are just Darwin Award winners.
Emotional. It doesn't address the issue. Gardasil is the new fad drug for a rare disease.
A friend of my sister in law was preparing for her 25yo daughter’s wedding when a routine pap smear revealed stage four cervical cancer. I don’t know her status today but cervical cancer is no joke.
I am concerned about Gardasil though, I got an ulcer from Celebrex, interestingly enough, the only one of the cox inhibitors still available. When I had my ulcer, they switched me to Bextra, same result but they ended up pulling both Bextra AND Viox, even Celebrex was off the market for a while so while I hope Gardisil is safe, I hope we don’t end up with a 21st century Thalidomide.
As for the cancer being the result of multiple partners, why not reduce the risk for everyone although I would not make it prescribable by law like I believe Texas wants to do.
So people with multiple partners deserve to die? What about smokers or people who consume alcohol, are they on their own too?
Why should my non-sexually active 11 year old daughters get this vaccine, especially when they have to get the booster 5 years later?
I know they are not sexually active.
I figure when they are old enough to drive there is a greater risk for them being sexually active. At 16, we’ll figure out if they should have the vaccine.
However, one of my daughters has a brain injury and now has a seizure disorder. I think I won’t recommend this vaccine at all to her. I think the benefits don’t outweigh the risks for her.
I certainly am not for stopping regular Pap screens. I just don't believe in cramming more toxins in children for a rare disease. If you have daughters and want to do that, it is your right as a parent. Just don't insist that mine be given it also.
Where did I say that? If you click the link that I provided you will see smoking on the risk list. So is oral birth control and not eating enough veggies. My problem is forcing the drug on children. AND Merck not being entirely honest.
I’m not insisting on anything. I oppose making the vaccine mandatory. I simply strongly recommend it. I’m a pathologist and have often diagnosed this “rare” disease. I’d rather not have to do that.
My problem is forcing the drug on children. AND Merck not being entirely honest.
I have the same concerns, when I was given Bextra, it had just came on the market. I'm all for fast tracking drugs but couldn't they test them on congress or something?
The optimum time to vaccinate is before sexual activity starts.
I want to add that multiple partners spread the virus and increase your odds of getting it.Also I believe Gardasil is aimed more at the genital wart outbreak. It has become a problem but the cancer scare sounds more dramatic.
There is also this on Mercks Gardasil page.
HPV is a common virus. In 2005 the Centers for Disease Control and Prevention (CDC) estimated that 20 million people in the United States had this virus. There are many different types of HPV. Some cause no harm; others can cause diseases of the genital area. For most people, the virus goes away on its own. When the virus does not go away, it can develop into cervical cancer, precancerous lesions, or genital warts, depending on the HPV type.
If you live in one of those states that require that she does, I would protest. Keep her at home the day they give them.
There is a problem with multiple partners as I say in my post 71.
I'm all for fast tracking drugs but couldn't they test them on congress or something?
*snicker* Gardasil doesn't cure disease. lol
Well, I knew that gardasil would turn our daughters into sluts. It would appear that some of the recipients were sluts already.
Why 'NO WAY!'? Suppose your daughter has the strength of moral conviction and character to remain a virgin until her wedding night, but her husband had fallen into fornication and later repented, or was himself a virgin on their wedding night, but became an HPV carrier by vertical transmission from his mother? Or, contrariwise, suppose despite your best efforts to raise a moral daughter, she falls into fornication. I suppose cancer years later is just fine with you as a parent, as an infliction of stern divine justice?
About 5% of cases of the strains of HPV that cause cervical cancer are classed as non-sexually transmitted--and that on the basis of assuming that anyone who is sexually active and has the virus got it sexually, suggesting that the actual percentage of non-sexually transmitted cases is higher. Most of these are probably 'vertical transmission', mother to child, but there is even a documented case in which a pair of twins shared clothing, and the twin non-sexually active got the virus by sharing clothing with her sexually active sister.
Truly emotional reaction since HPV is spread sexually.
So is pregnancy.
Pregnancy is a disease on par with cancer and genital warts? Who knew?
I was raised by a lady.
I am a lady.
I am raising my daughter to be a lady and my sons to be gentlemen.
My children were just 5 years old when I started telling them about how special marriage is. My children already know that you don't snuggle in a big bed unless you are MARRIED. God doesn't like it.
Ironic, isn't it, that people laugh at God's plan for us, mock it as unattainable or "old fashioned," but are somehow surprised by all the misery that comes when they deviate from it(adultery, out of wedlock babies, broken homes, teenage pregnancy, etc., etc., etc.)
No thanks. My family will stick to God's plan.
If they wait to have sex until they are 16 or hopefully older, then why would you give it to a young girl.
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