Not everyone loves Gardasil

In addition to the moral debate that surrounds giving Gardasil, Merck’s new HPV vaccine, to young girls, the National Vaccine Information Center (NVIC) is also urging against a “universal use” recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP) on June 29th. The NVIC doesn’t feel that Merck’s clinical trials proved that the HPV vaccine is safe for young girls.

    “Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

    The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.

    Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. Pain and swelling at injection site and fever occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

Hmm. This certainly throws a new wrinkle in the story.

You can read the full article over at Red Orbit.

This entry was posted in Gynecology, Midwifery, New Products, Politics, Primary Care, STIs, Women's Health. Bookmark the permalink. Trackbacks are closed, but you can post a comment.

8 Comments

  1. Posted June 28, 2006 at 5:34 pm | Permalink

    I’m due with my first baby (actually I was due last week, but no baby yet) and had an interesting experience when I was interving pediatricians a couple of weeks ago. While we were discussing vaccinations, one of the peds was encouraging us to consider giving Gardasil to our infant. . . I have been watching news about this vaccine with interest for several years (I was actually part of a clinical trial when I was in college and needed cash) but I have never heard anyone suggest that it should be used in infants, or that it should be added to the list of regular newborn vaccinations.

  2. The Student
    Posted June 29, 2006 at 7:21 am | Permalink

    Wow, I can’t believe they were offering it to a *baby*. NONE of the clinical trials were tested on anyone younger than 9, and the safety of the vaccine is already being questioned for that age group. That pediatrician is offering medical advice that isn’t evidence based, which is pretty scary. What was your reaction?

    Good luck with the last few days of your pregnancy (which will hopefully end soon?) and good luck with your birth! Congratulations.

  3. Posted July 1, 2006 at 7:34 am | Permalink

    I think this doctor just didn’t know what he was talking about. . . I did not like him for other reasons anyway, so we will be taking the baby to someone else.

  4. Jaws
    Posted July 2, 2006 at 5:50 pm | Permalink

    I thought that certain strains of HPV were considered to be *associated* with cervical cancer, and that the jury was still out on whether there is a direct causal relationship leading from the HPV to the cancer. I haven’t heard this mentioned, however, in the current vaccine debate (or any of the commercials, surprise, surprise), even from you. Give me the straight dope, student!

  5. Jaws
    Posted July 3, 2006 at 10:37 am | Permalink

    Oh yeah, I’ve also read that heavy metals in infant vaccines are prime suspects in the skyrocketing rates of autism in the US. That possibility alone aught to give any doctor pause before suggesting the addition of yet another heavy metal-based vaccine to a baby’s battery of vaccinations! I think Joanne definitely made the right decision not to go with that pediatrician.

  6. The Student
    Posted July 3, 2006 at 4:33 pm | Permalink

    Hey, Jaws:

    I am not 100% certain on this, and I will absolutely do a little more research for you, but I think it goes like this: not every strain of HPV will cause cervical cancer, but if you get cervical cancer, chances are 99.999% (I’ll find you the real number) that it was caused by HPV. But this is an awesome research question. I’ll figure it out, just as soon as I unpack my textbooks (almost all of my stuff is still in boxes atm, and probably will be until we paint our apartment).

  7. Posted July 6, 2006 at 3:00 pm | Permalink

    i love reading your blog! :)

  8. k
    Posted July 6, 2006 at 11:12 pm | Permalink

    I have HPV, I have had seven “iffy” results on pap tests… Cancer has been mentioned several times, in the Cancer Care Centre I was sent to. So JAWS, yes it is associated directly with cancer. *Autism is a nasty random disease… ask my friend in NYC with her non-immunized triplets, two at the severe end of the “spectrum”. I’ve taken to questioning every single thing from the medical community… always. I’m with Sage Femme love it here.
    I’m just starting to pack boxes, can’t even imagine all the unpacking to do at the end….. ick ick ick!

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