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?