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.
True. But my married daughter, age 26, was asked by her OB/GYN if she wanted the vaccine when she went for her first pre-natal visit.
She, of course, declined.
Thats sort of the point with vaccines. They don’t work once you have the disease. You have to take it when you are healthy. Wide spread vaccinations practically eliminated some diseases, but the people too lazy or too paranoid to get vaccinated have provided hosts for some of these diseases to hang around and in some cases make a comeback. It’s too bad.
This is the ONLY time in history that anyone has ever suggested a vaccine for a disease that IS NOT TRANSMITTED THROUGH NORMAL, EVERYDAY CONTACT. This is being touted as some sort of wonder drug and we have no clue what it will do to the developing reproductive systems of young girls. For all we know this is the next thalidomide.
Not at all. I said hopefully she won’t since she won’t be protected. Safest would be no sexual partners for her.
No. Go back and read the posts 9, 14, and 19. The word is miscarriage. They also would have noted other complications in those pretrial studies.
"Moreover, there have been no studies to determine what may happen all of these eleven year old girls are marrying and trying to have children in a decade or so."
The general knowldge and understanding of the immune system and the response to such a vaccine says there would be no effect. The only effect possible would occur if the baby produced and presented the antigen contained in the vaccine. Babies just don't produce the HPV antigen, so the concern is simple illogical nonsense.
Women and Men in the United States: March 2002
In 2002, the population of women in the US was 144 million.CDC Cervical Cancer Statistics
1,820 women were diagnosed with cervical cancer in 2003
3,919 women died from the disease that same year.
Dividing 11820 cases by 144 million women comes out to 0.0008208 or 0.08208%.
Less than 1% of the female population die from cancer but Merck doesn't tell you that. Nor do they tell you that the American Cancer Society now classes cervical cancer as a rare disease.
A little more perspective. Cervical cancer is the second leading cause of cancer death among women worldwide. It would be the same in the US if not due to mass Pap smear screening. Well over one million American women every year are diagnosed with pre-cancerous changes on Pap smears and require additional treatment or close followup. Gardasil and the other vaccines have the potential to prevent an enormous amount of human suffering, not to mention saving money.
And, it’s probably even rarer among those who don’t do multiple, random “hook-ups.”
Your keyword is “worldwide”. Less than 1% of American women die. It’s easily detected and treated in the US. If those in foreign countries want their daughters to take it, fine. DON’T push it on ours OR use half truths and scare tactics to make money.
Sex isn’t normal? It happens everyday all the time. Indeed none of us would be here if it wasn’t for sex.
“This is being touted as some sort of wonder drug and we have no clue what it will do to the developing reproductive systems of young girls. For all we know this is the next thalidomide.”
if it can eliminate most cervical cancer, then that pretty much qualifies it as a wonder drug. Since most women seem to be able to have normal children even after being vaccinated while pregnant, it wouldn’t seem to have any adverse actions on reproductive systems. Certainly not as adverse an action as HPV has on female reproductive systems.
If there have been no tests on DEVELOPING reproductive systems, then you may have a point. When hundreds of thousands of girls in the three states where mandatory vaccinations are required, reach child bearing age and can’t reproduce. I imagine the governors and anyone else responsible will have to literally run for their lives. I don’t support mandatory vaccinations BTW.
You got that right!
A high number of sexual partners.
Without knowing additional statistical data, I see no reason to think these miscarriages wouldn't have occurred anyway.
“3,919 women died from the disease that same year.”
Very comforting, unless you or a member of your family is one of those 3,919 women.
The reason that so few American women die in the US is due to mass Pap smear screening. We perform approx. 60 million Paps per year in this country of which 7-8% are abnormal. That means that around 4.5 million women require additional testing or treatment. This is how we've lowered the death rate so dramatically. This process is expensive, highly intrusive and often causes great distress among women. Vaccination has the potential to both prevent suffering as well as save money right here in the US.
For the record, I don’t oppose this vaccine per se, my problem is with the way they are trying to force it on everyone.
Unfortunately, there are a lot of teens and young women who do NEED this vaccine. It is also unfortunate, that many of them won’t realize that this DOES NOT protect them against a deadly array of other STDs. I do believe that it is quite reasonable for a girl to remain a virgin, marry someone who is disease-free and NEVER need to worry about this disease and these girls do not need this 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.
Yup. Can't win on facts so let's use emotion! Guilt trip!
Won't work. Merck is scaring women into giving a vaccine to their daughters for a RARE disease. AND making money on it. Less than 1% contract cervical cancer. So who is using a bogeyman to line their pockets?!
Oh and see post 52. One of the risk factors is multiple partners. Educating girls that they could die having a good time is a lot safer than filling them full of drugs.
Ban the FDA!
Is that why they’re still pushing Pap smears? I’ll tell you what I just said to someone else. It ain’t worth it. Pap smears have made this a rare disease. Educating young women that multiple partners can kill them makes a LOT more sense than filling a kid full of drugs for a RARE disease. Does ANYONE tell them that they can CATCH the cancer causing virus from sex? Doubtful. But hey....Now there’s Gardasil and it won’t matter. Unless it’s Aids, chlymidia, syphilis etc. We are telling our kids the wrong thing..........”Don’t do it but here’s this drug in case you do. Side affects? Um.....”
So screw those 3,919 dead women. OK, fine, but what about all the women who contract HPV and don’t die, but can’t have children because of it? Screw them too?
“One of the risk factors is multiple partners. Educating girls that they could die having a good time is a lot safer than filling them full of drugs.”
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. I guess those who screw up and catch HPV are just Darwin Award winners. Losers in the evolutionary game right?
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