Saturday, February 7, 2009

Comparing Side Effects from Gardasil and Menactra

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News reports about Gardasil have focused on an increasing number of formerly healthy, active girls who have suffered inexplicable weakness, paralysis and other devastating health downturns after receiving the vaccine. There is not always a clear causal connection, but girls like Ashley Ryburn, Gabby Swank, Christina Tarsell, and Jenny Tetlock put a face on what may be the dark side of the vaccine.

Now the National Vaccine Information Center has taken a more statistics-based look at the total side effects and adverse events reported to VAERS for two recommended vaccines, Menactra and Gardasil.

Both vaccines are aimed at the same population of 11-12 year-olds through college-aged kids.

Menactra, approved in early 2005 for preventing meningitis, is approved for both males and females up to the age of 55 but is mostly used for the young crowded-living crowd. It has not been marketed nearly as aggressively as Gardasil. Gardasil, of course, was launched with a very controversial and effective sales campaign in mid-2006 as a preventative for HPV, but is so far approved for use in young girls only.

As studies go, this one is flawed, although in general it isn’t unreasonable to consider a comparison. It provides no information about how many people actually received the vaccine, and a per-dose analysis, if available, would be somewhat fallacious given that Menactra is a one-dose vaccine and Gardasil is a three-dose vaccine, with some people potentially not returning for the second or third shots. * See end of post for update from NVIC.

But that’s no reason not to cast at least a jaundiced eye over the comparison.

NVIC reports that Gardasil is associated with twice as many emergency room visits, four times as many death reports, five times more ‘did not recover’ reports, and seven times more ‘disabled’ reports.

There were also 23 reports of blood clots with Gardasil and none with Menactra. However, given that rightly or wrongly the FDA has put almost all the blood clot reports down to birth control pills, and Menactra is also approved for boys (not usually too fond of taking the Pill except as a hazing ritual), this one isn’t exactly a slam dunk.

57 kids who got the Gardasil shot alone developed arthritis, compared to six who got it with the Menactra shot, and 12 who got Menactra alone or with another vaccine.

Gardasil takers suffered four times as many cardiac arrests, four times the number of cases of Lupus, 15 times the number of strokes, and 34 times the number of thrombosis. Etcetera, etcetera. For the full report, and for the full details of how often the two vaccinations were given together, go to nvic.org.

All this, alas, would be far more meaningful with the addition of an accurate count of those who received each vaccine.

One also has to consider that VAERS, the Vaccine Adverse Event Reporting System, is prey to both under-reporting and over-reporting. Under-reporting occurs when no-one connects the dots, or a doctor dismisses a patient’s concerns, or flat out doesn’t bother. It is estimated that at least 90% of adverse events and side effects go unreported.

On the other hand, over-reporting occurs when people connect the dots wrongly and simply blame a kitchen sink of symptoms on a vaccine. Gardasil, with its aggressive approval and marketing campaign, has made itself particularly vulnerable to this.

The CDC continues to recommend Gardasil, saying that it is safe and effective and that its benefits outweigh its risks; and it of course is still monitoring the situation.

NVIC is a national non-profit educational foundation that was founded by the parents of children who have been damaged by vaccines. Although it opposes only mandatory vaccination, not vaccination in general, it encourages parents to make informed choices and lobbies for increased safety.

*A researcher from NVIC sent the following comment:

"according to the sources below, the two vaccines were licensed about a year apart and about the same number of doses of each vaccine have been sold. But, because Gardasil is a three-dose series, there are probably about three times more people who received Menactra than Gardasil. So, the fact that a much larger number of serious adverse reactions were reported for Gardasil than Menactra suggests that there's a serious problem related to the reactogenicity and safety of Gardasil.Gardasil: 16 million doses in US distributed as of June 30, 2008: http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htmMenactra: 15 million doses in US distributed as of February 26, 2008: http://www.cdc.gov/vaccinesafety/concerns/gbsfactsheet.htmSo, if Gardasil was no more reactive than Menactra then we would expect the number of adverse event reports to be about 1/3 of what was reported for Menactra. It's the exact opposite and then some."

Do you have any experience of either of these vaccines? If so, have you experienced any side effects or adverse advents, and have you reported them to VAERS or another drug rating mechanism? Do you see any value to the Gardasil-Menactra comparison?

8 comments:

Anonymous said...

Actually, I think this is a very useful analysis and less flawed than you may think - ignoring the unavoidable problems inherent to VAERS and that information about how many doses of a particular vaccine are sold or administered in the US is proprietary and almost impossible to get. This limitation is one of the reasons why computing comparable rates of adverse reactions by vaccine or to the unvaccinated population is so difficult. (Never mind that rates of adverse reactions among the completely unvaccinated population aren't known and therefore, CDC is stuck comparing rates of adverse reactions among one vaccinated group to rates among another vaccinated group. A bit circular and nonsense? No wonder vaccines are almost always cleared of being associated with adverse reactions.)

Anyway, according to the sources below, the two vaccines were licensed about a year apart and about the same number of doses of each vaccine have been sold. But, because Gardasil is a three-dose series, there are probably about three times more people who received Menactra than Gardasil. So, the fact that a much larger number of serious adverse reactions were reported for Gardasil than Menactra suggests that there's a serious problem related to the reactogenicity and safety of Gardasil.

Gardasil: 16 million doses in US distributed as of June 30, 2008: http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htm

Menactra: 15 million doses in US distributed as of February 26, 2008: http://www.cdc.gov/vaccinesafety/concerns/gbsfactsheet.htm

So, if Gardasil was no more reactive than Menactra then we would expect the number of adverse event reports to be about 1/3 of what was reported for Menactra. It's the exact opposite and then some.

The entire report is worth reading. http://www.nvic.org/

Plus, NVIC has a detailed questionnaire for people suffering Gardasil reactions and some new community support forums.
http://www.nvic.org/Forums.aspx

concerned.about.vax.safety@gmail.com

Anonymous said...

I am the mother of Ashley Ryburn. It has been 9 weeks and 3 days since we have connected the dots to this vaccine. Ashley had the vaccine in 2007. She has been ill for so long and we didn't know why.
We are much more educated now. Thanks to the NVIC,Barbara Loe Fisher, Cynthia Janak, Leslie Botha and Dr. Mark Flannery.
After Ashley's story ran, we have been in contact with many families in our area who have affected daughters. To which the Colorado Health dept quoated saying they had no problems.

Well I think they do now. How many girls are out there and do not know why they are ill? How many unknown deaths are there?

Ashley only had two of the three doses. She was in the hospital at the time she was due for the third. I know now if she had the third, she wouldn't be here to tell her story.

I am lucky. I am now educated. Ashley and I are finally seeking the treatment she really needs.

It is costly treatment. If any would like to, our bank opened an account to help with medical costs. Bank of the West Ashley Ryburn Medical Fund.

Respectfully, Lisa Holtman

Kristin Johns said...

To first person who commented:

Thanks so much for the info—that puts it into perspective. Has the CDC responded to your analysis; or have any doctors/researchers commented? It certainly makes for interesting reading.

Something that I always wonder about is combinations of things. According to the CDC, when there’s no clear causal connection between Gardasil (or some other drug or vaccine) and X reaction, it “couldn’t” have happened; whereas in fact there could be a connection between the drug/vaccine PLUS a nearby crop spraying, or a genetic predisposition, or some virus that you didn’t even know you had, or some other trigger factor. I have a friend who’s allergic to neither shellfish nor wine, but had a life-threatening reaction when he had them together. Such things are hard to figure out.

If you know people who have had the Gardasil shots, you might want to suggest they fill out the Gardasil survey (or surveys for any number of prescription drugs) on www.RateADrug.com, in addition to the NVIC survey. The site’s intent is to collect information publicly where it can be easily searched and used to add anecdotal information to standard drug information. Patients can evaluate their own experience and then, when enough people contribute, potentially identify unknown or under-reported side effects—as well as the kind of side-effects where your doctor keeps telling you ‘there’s no connection’ while you know in your gut that there is. You don’t have to give your name and it’s not a lawyer feeder.

Kristin Johns said...

Ms. Ryburn, I can’t tell you how sorry I am about everything your daughter and family are going through. It must be really terrifying. Not knowing exactly what you’re dealing with is awful; I’ve gone through a little of that with one of my kids.

All the stories I read, including Ashley’s, break my heart, particularly because I have two daughters myself. In fact, this blog is my attempt to sort through all the information that keeps coming out even while I’m facing a fair bit of pressure to get Gardasil shots for the girls (ages 12 and 16). I would frankly dismiss the idea out of hand, except that I also know two people who’ve had quite serious problems with HPV (although both had other risk factors).

Have all the families you’ve been in contact with reported these side effects to the CDC? And has the Colorado Health Department responded?

You and Ashley are very much in my thoughts—I do hope you’ll find some solutions soon and Ashley will get back to her old self. It sounds like a long and hard road.

Kristin Johns said...

Ms. Holtman,

Oops--my apologies for getting your name wrong. I should know better; my kids and I also have different last names.

HIVlover said...

Yes, there maybe different result on people. I think it is ok

Anonymous said...

the fda and cdc bow to the drug companies. what they did with gardisal should have been illegal - especially having gov't officials who sit on the drug co boards promote and "force" our girls to get the vaccine.

i never got my son the chicken pox vaccine, i didn't trust it. and now, i am doing the research re: menactra. thank you for your information here and links to start from.

i am sorry to hear about ashley. i wish her well and perfect health very soon. hopefully, this administration will focus more on the health of our children and not lining their pockets.

Kiera said...

Please watch and post this video to your site... most people just aren't educated enough and we are allowing our government to instruct and require certain forms of health care without getting the facts straight first... very frustrating as a mother of three toddlers w/ a medical background and a husband that is a doctor... we haven't vaccinated our children at all and don't intend to.

Video link: http://video.google.com/videoplay?docid=-8119523476709184666&hl=en