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.
Well then why don’t we just vaccinate them before they leave the hospital?
And good for you on telling the Doc to pound sand!
This is why I only use drugs that the FDA says are bad for me.
Actually, no. Current guidelines call for Pap smears every other year until age 30 and every three years after that, provided the Pap smear and simultaneous HPV test are both normal. These guidelines haven't been modified to reflect the effect of vaccination yet since the vaccines are so new, but I expect that vaccinated women will be screened at less frequent intervals as well. Still, you're right that the need for screening will not disappear completely for several decades at least.
Most kids don't tell their parents when they become sexually active. I've personally diagnosed abnormal Pap smears in girls as young as 11 and these weren't cases of sexual abuse (at least the way we usually think of sexual abuse).
I made a typo in what I wrote, I meant to say that this is the first time that anyone has ever suggested a MANDATORY vaccine for a disease which is not transmitted through normal, everyday contact.
I’m a stay at home mom. My twin girls are in a small private Christian school that is very well supervised.
One of my daughters has seizures, so we have a baby monitor in her bedroom.
Let’s just say, my girls don’t have a lot of privacy.
The one that would be likely to have sex young is the one with seizures. However, she is not to go to anywhere at school alone.
My other daughter is extremely serious. She does not like things like High School Musical. She’s into academics and band. She’s also a bit geeky.
I know my girls are not going to have opportunities to be alone with boys, so I’m not really concerned about them having sex. When they can drive, I’ll be more concerned.
However, I know my one daughter will wait to have sex until at least college (and probably until she is married).
I’m not so sure about my daughter that has seizures. She’s already interested in boys. However, I doubt I’ll let her have the vaccine because one of the side-effects is seizures. I’d rather just have her get pap smears. She goes to the doctor a lot anyway, so the doctors will be on top of things with her.
Sounds like everything should be fine. I can only talk in general terms when I recommend the vaccine. Approximately 80% of American women are infected by one form or another of HPV in their lifetimes and 50% within three years of becoming sexually active. Fortunately in most cases these infections are transient. But 80% is a lot and some of them will go on to develop precancerous lesions and even cancer. Screening is very helpful but 30% of women with cervical cancer in the US are screened regularly. Pap smears aren’t perfect.
Well, considering that 15 to 20 percent of all pregnancies end in miscarriage, the law of averages dictates some women getting the vaccine are going to miscarry, regardless of what you’re injecting. You could give the girls placebos and the same thing will happen.
Granted, mandatory HPV vaccinations of little girls is horrific, but just argue that point without cooking up what is likely a phony-baloney terror story.
My goal is to postpone the test as long as possible for a couple of reasons. One is because I don’t think it is necessary until my daughters are sexually active.
However, I’m hoping they figure out more of the side-effects and come up with a safer vaccine.
They did that with the DPT vaccine. The DPaT vaccine is safer for kids prone to seizures.
In 5 years when my daughters are 16, I think we’ll have a lot more information about this vaccine. Plus, my daughters will be much better able to make a better informed decision about this.
Right now, I’m not even liking the idea of giving the regular booster shots to my daughter that started having seizures. She’s up for the shots now, but I’m waiting a few more months until we know that she is on medication that is controlling her seizures.
How true
Smart Lady. The vaccine itself only protects against a few strains of the STD that causes cervical cancer. And there are no long term studies done either.No daughter of mine is going to be a guinea pig.
I guess I must be very old fashioned.
I thought all mothers when they hold their baby girls in their arms were thinking of all the future days of innocent childhood, happy school days,a blessed Wedding Day with their one true love, and seeing their grandchildren.
Now I guess we tell our girls to have recreational and not procreational sex anytime (following Planned Parenthood’s propaganda) they feel like it exposing them to who knows how many STD’s and broken hearts along the way.
And maybe that is why we see so many young women who aren’t so innocent,possible infected, aren’t so happy and not getting married anymore.
Check out post #79. You and I are BOTH old fashioned.
I've also got two boys I am raising to be gentlemen.
If you have a little girl you're raising as a lady, let's get them together!
Amen.
My sons may be a little to old for your little girl but there is one thing I know. They are kind and thoughtful gentlemen who love God and their families.
I agree with that! They cause de facto bans on very helpful medications, while being political on their allowing of others.
I've never known an employee of the FDA who was not very liberal. I'm sure that's not representative overall, but the sample sure makes me wonder.
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