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FDA: 28 Miscarriages No Reason to Reexamine Gardasil
CNSNews ^ | 12/6/2007 | Fred Lucas

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.


TOPICS: Culture/Society; Front Page News; News/Current Events
KEYWORDS: gardasil; hpv; miscarriages; moralabsolutes; vaccine
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To: monday

I don’t. Plus, when you have a child with brain damage, you can easily opt out of most vaccines.

So far, the benefits of the vaccine usually outweigh the risks, but I don’t think on this one they do.

For example, my daughter just got her flu vaccine. Well, she had her first grand mal seizure on October 1 when she had a mild cold. The doctors said that getting sick will lower her seizure threshold, and we don’t want her to have another grand mal seizure. On top of that, she also has a heart arrhythmia and asthma. She doesn’t need to get the flu. The flu vaccine typically doesn’t cause seizures either, like the gardisil vaccine does.


81 posted on 12/06/2007 1:32:11 PM PST by luckystarmom
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To: TheWriterTX

see #45


82 posted on 12/06/2007 1:35:39 PM PST by monday
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To: DJ MacWoW
Mothers and babies do die. In fact there are 3 times as many pregnancy related deaths per year as there are cervical cancer deaths.

US: 14 maternal deaths per 100,000 live births, 4 infant deaths per 1000 live births. That's 414 deaths for every 100,000 pregnancies. Almost 3 million births per year that's 12,420 pregnancy related deaths per year.

Only 3,700 cervical cancer deaths per year in the US.

Sources - WHO and American Cancer Society.

83 posted on 12/06/2007 1:41:35 PM PST by CholeraJoe (Vote for Mike Huckabee or Chuck Norris will give you a wedgie!)
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To: CholeraJoe

Uh...............ok. Pregnancy isn’t a disease so I have no idea what your point is. But, hey, have fun!


84 posted on 12/06/2007 1:43:38 PM PST by DJ MacWoW (Jesus loves you, Allah wants you dead)
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To: DJ MacWoW
Pregnancy is a disease on par with cancer and genital warts? Who knew?

Touchdown. ;)
85 posted on 12/06/2007 1:43:56 PM PST by arderkrag (Libertarian Nutcase (Political Compass Coordinates: 9.00, -2.62 - www.politicalcompass.org))
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To: spunkets

As a side note, the vaccine is effective for 5 years and currently, no booster exists. There is work in development.


86 posted on 12/06/2007 1:50:01 PM PST by trimom
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To: monday
Thanks, Monday. I didn't catch that later response since I wasn't pinged to it.
87 posted on 12/06/2007 1:51:01 PM PST by TheWriterTX (Proud Retrosexual Wife of 14 Years)
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To: monday
"So screw those 3,919 dead women."

Why are you advocating mass necrophilia?

88 posted on 12/06/2007 1:54:08 PM PST by verity ("Lord, what fools these mortals be!")
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To: monday
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.

Polio was nearly eradicated, but it's making a comeback in areas of Africa where a widespread rumor was that the vaccine was cover for a plot to sterilize Muslims. Vaccinations resumed after the NGOs started buyng vaccine from Saudi Arabia, but the effort w as set back years, if not decades. Polio is, like smallpox, a good candidate for eradication -- both diseases have no hsts other than humans, so they're not lurking in the forest waiting to resurface.

89 posted on 12/06/2007 2:11:12 PM PST by ReignOfError
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To: wagglebee
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.

Most forms of hepatitis are not spread through casual contact. In addition, research is well underway for vaccines for gonorrhea, syphilis, genital herpes and HIV. None have yet proven safe and effective, but to say that no one has suggested such a thing is absurd.

90 posted on 12/06/2007 2:24:12 PM PST by ReignOfError
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To: Lx
I hope we don’t end up with a 21st century Thalidomide.

Interesting that Thalidomide has come up twice in this thread. Interesting because Thalidomide is by and large a success story for the FDA. While the drug was in widespread use around the world, in the "mother's little helper" era when sedatives like Valium and Haldol were being tossed around like candy, with Big Pharma lobbying like crazy and pregnant women clamoring for it, one stubborn and skeptical FDA investigator kept demanding more studies before granting approval.

Frances Kelsey was troubled that the drug hadn't been tested on pregnant females in the animal trials. In fact, in clinical trials at the time, it was fairly common to conduct clinical trials on men, cavalierly assuming that the side effects on women and children would be the same. Thalidomide blew the doors off that assumption.

Thalidomide was never approved for use in the United States, though it was prescribed to thousands of patients as an "investigational" medication, legal at that time. In the end, something around 12,000 thalidomide babies were born worldwide, 17 of them in the US.

Numbers from Wikipedia, so take them with a grain of salt, but the article appears to be solidly sourced.

91 posted on 12/06/2007 2:46:54 PM PST by ReignOfError
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To: jalisco555

Given that this ‘vaccine’ doesn’t prevent ALL types of cervical cancers, yearly pap smears are still required for detection of cancer.

So what does this ‘vaccine’ buy us?

My daughter didn’t get it either.


92 posted on 12/06/2007 3:02:12 PM PST by CatQuilt (Fred's the one in 2008!)
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To: DJ MacWoW
I want to add that multiple partners spread the virus and increase your odds of getting it.

Of course. That's true of any STD, or for that matter any communicable disease -- the more vectors, the greater the risk. The more times you throw the dice, the greater the chance they'll come up snake-eyes.

This is just anecdotal, but the folks I know with small children get a lot more colds in the average season than single folks or young couples without children. Kids are susceptible, they're in large groups in close contact, and they aren't always rigorous about covering their moths when they sneeze or cough or washing their hands. A classroom is a near-perfect incubator.

Then there's the 1918-19 flu epidemic, no doubt aided in its spread by World War I -- take a bunch of men from all over the world, carrying God knows what, gathered together in barracks, ships and trenches in close quarters, and a virus jumps from host to host like a frog hopping from one lily pad to another.

Of course, now we have folks from all over the world packed into shiny airliners with limited ventilation all day every day, so there are more disease vectors on an average unremarkable day than there were in the Great War.

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 would probably be an effort to produce a vaccine even if it were just about genital warts, which are problematic but not life-threatening. There are vaccines under development for gonorrhea, chlamydia and syphilis, which can usually be cured with antibiotics if detected; for genital herpes, which is permanent but not life-threatening; and for HIV, which is of course terminal.

The cancer angle makes the HPV vaccine more compelling that the others. The death numbers for uterine cancer are relatively low, but they are not the whole story -- add in the screenings, the follow-up screenings, hysterectomies, radiation, chemo and the lurking fear that the cancer will come back, and there is a whole lot of expense and suffering that could be avoided.

93 posted on 12/06/2007 4:09:52 PM PST by ReignOfError
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To: ReignOfError
Of course. That's true of any STD, or for that matter any communicable disease

True but we're talking about a dice roll that need NOT be taken. Catching a cold at work isn't quite the same as taking a chance on contracting an STD for a few moments pleasure. Sex isn't a recreational sport. Unless you ask a liberal.

The death numbers for uterine cancer are relatively low, but they are not the whole story -- add in the screenings, the follow-up screenings, hysterectomies, radiation, chemo and the lurking fear that the cancer will come back, and there is a whole lot of expense and suffering that could be avoided.

I worked it out and it's 0.08208% of the population that contracts cervical cancer. That's not an epidemic worthy of mandating the vaccine for prepubescent kids. If a parent WANTS their child to have it, fine. Polio, whooping cough, measles..........they were epidemics. This is not.

Btw, I also read on a Gardasil thread a while ago that most women who die from cervical cancer usually don't get Pap smears. It was some study that was cited. If they don't get regular Paps, why would they bother with a vaccine?

94 posted on 12/06/2007 4:30:00 PM PST by DJ MacWoW (Jesus loves you, Allah wants you dead)
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To: CholeraJoe

I would really rather postpone this until we have more data.


95 posted on 12/06/2007 4:44:28 PM PST by secret garden (Dubiety reigns here)
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To: wagglebee
Go back an read the article again, it does not say this at all.

No, it does not say 28. It does say that the number of AEs related to pregnancy (without specificity) occured in both placebo and active groups of the Phase III trials with Gardasil. Translation: There is no statistically significant difference in the rate of Adverse Events related to pregnancy in those who have received a Gardasil vaccination and those who have not.

96 posted on 12/06/2007 5:20:30 PM PST by the808bass
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To: wagglebee
This has NOTHING to do with miscarriages and all this is saying is that the rate of pregnancy complications is the same.

Miscarriage is a pregnancy complication.

97 posted on 12/06/2007 5:21:56 PM PST by the808bass
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To: Pyro7480

Unless they compare it with how many miscarriages would be expected without Gardisil this is not meaningful.

Judicial Watch usually does their homework. So I wonder why they would omit the data would have made this meaningful?

This reminds me of the people who talk about the number of non-combat deaths in Iraq but don’t compare it with the number of deaths that occur normally among 150,000 men and women.


98 posted on 12/06/2007 5:27:08 PM PST by gondramB (Preach the Gospel at all times, and when necessary, use words.)
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To: Pyro7480
I have some venting to do. Today my 12 year old’ Dr. advised me she should get a Gardasil shot. I immediately interrupted her and said not until she is much older. The Dr. replied “she will be having sex in high school” I was livid I shot back she will not she is being raised with morals and will wait till marriage. Not only did the biach say this but my 12 year old was in the room. I was livid. I had to go through the whole abstinence speech with her and I feel 12 is too young. I am findiing a new Dr. tomorrow. My mom called her a Liberal bitch.
99 posted on 12/06/2007 6:06:59 PM PST by angcat ("IF YOU DON'T STAND BEHIND OUR TROOPS, PLEASE FEEL FREE TO STAND IN FRONT OF THEM")
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To: angcat

I’m so sorry. WHY do these idiots think they know our kids better than we do? The press hammers away at “They ALL do it” and then a study comes out that shows the lie. Hang in there. No one knows your baby like you do.


100 posted on 12/06/2007 6:14:56 PM PST by DJ MacWoW (Jesus loves you, Allah wants you dead)
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