Monday, January 12, 2009

Miscarriages? 44.6 Percent Increase in Lesion Potential? No Wonder the FDA Refuses to Allow Gardasil for Older Women.

The FDA has once again denied Merck’s application for its Gardasil vaccine to be used for women aged 27 to 45, asking that the drug company first complete a 48-month study and submit the data. Frankly, it’s only surprising that Merck even applied at this point.

Not only does Gardasil not cure existing cases of HPV but it can also apparently create a problem if you already have HPV—as do many, or even most, sexually active women at some point in their lives—when you get vaccinated.

Nearly all cases of HPV, caused by any of perhaps 35 different viruses, are self-limiting. In other words, they fix themselves unless for some reason you have a weakened immune system. But background information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) back in May 2006 reveals that when the vaccine is administered to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by a whopping 44.6 percent. Ouch. Merck played with the figures after deciding that the groups were "unbalanced," eliminating women who were at higher risk anyway because of, say, a smoking habit. That put the Gardasil advantage slightly into the positive territory. After the numbers were all reconciled, the added risk was some 11 percent.

If that doesn’t give pause for thought, then potential issues with pregnancy might.

Merck initially reported to the FDA that 27 percent of pregnant women had an adverse reaction to the shot and noted that "it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman."

The Vaccine Adverse Event Reporting System (VAERS) further reports 45 cases of spontaneous abortion, or miscarriage, following vaccination with Gardasil. And when the vaccine was approved, five babies had been born with congenital birth defects after their mothers had been immunized with Gardasil within 30 days of conception, as opposed to a placebo group that had zero. Reports now put that number at anywhere up to 40.

To be honest, one can only wonder why the vaccine is approved for women in their teens or twenties. It would seem more intelligent to require that anyone getting the vaccine get a virginity test, a pregnancy test, and an HPV test before being jabbed…unlikely though that possibility is.

What do you think? Should Gardasil be approved for older women? Should HPV and pregnancy tests be mandatory before each of the three shots?


Anonymous said...

Cite your sources, MLA or Chicago style. Without citations, this is not only 100% plagiarized, it can not be taken as any form of truth. If your argument is true, please provide readers with the opportunity to view your sources and decide for themselves.

Anonymous said...

Plagiarized? From what? Could you tell me where you found this post previously?

The sources are cited within the post and are easily verified. Not all of us need footnotes and a link.

Anonymous said...

you said that people should have to get a pregnancy text and an hpv test the only problem with that is, there is no such thing as an actual hpv test. I had my yearly pap done only this time instead of all being normal they told me the cells were similar to those of hpv, they told me it should go away on its own and then gave me an hpv shot...I really dont know what to think about it i mean sure its suppose to help but i dont think it has been on the market that long and i know it hasn't been tested long enough to know the long term effects. It makes me kind of nervous at times but I guess i already made the decision and so did millions of other girls and the FDA wont take it off the market any time soon so i guess we just need to live with the idea that even the FDA is just made up of humans and we all make mistakes so if there are consequences people will sue and life will go on

Kristin Johns said...

Who told you that there's no such thing as an HPV test? If it was your doctor, you should fire him and get a new one as there most certainly is a readily available test for HPV.

I wouldn't worry too much about the infection; they mostly go away by themselves although your doctor will keep an eye on it. Unless you mean that you had evidence of pre-cancerous cells, in which case, treatment might be required.

Melinda said...

I had the Gardasil shot - it disrupted my birth control, and we got accidentally pregnant.

Further, it caused a defect in the formation of the placenta and umbilical cord. It nearly killed my child ... and, caused a retained placenta which nearly killed me during childbirth.

We are both lucky to be alive...and now I find out that my body will retain the 750 mcg of aluminum for years and years, meaning my baby is getting doses of aluminum through breast milk.

We called the CDC, the state, the FDA, and the pharmaceutical company ... due to Bush deregulation, they do not have to report problems outside their "controlled" studies. Nobody wants to count us among the statistical problems with this vaccine.

So when you are quoting these statistics about problems, realize these numbers are LOW estimates. People like me are not counted.

Kristin Johns said...

Melinda, I'm sorry about your experience--sounds horrible. I'm glad you're both OK. But I will say that Merck is REQUIRED to keep and report your info about Gardasil side effects. They maintain that most of the reports they get lack adequate follow-up contact info, so be sure that you give them a good phone number and address. Better still, send a certified letter.

You can also make a report to VAERS, again being sure to give good contact info. And please make a report on's an ongoing systematic survey on Gardasil, and eventually all anecdotal reports add up to act as "the canary in the coal mine."

I hope you and your baby continue to do well. Kristin

Anonymous said...

Can you please tell me where to locate the report from the 2006 VRBPAC? I have found information regarding the retention of aluminum but nothing referencing the increase in lesion potential. I am considering getting the HPV shot and researching info on side effects.

Anonymous said...

For Anonymous - The miscarriages are under spontaneous abortions page 143

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