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FDA Says Gardasil May Cause Fainting; The Stats Say It Doesn't

By Jim Edwards | Jun 15, 2009

The FDA has demanded Merck add a new warning to its Gardasil HPV vaccine: That it may cause fainting. The news is already being hyped as yet more “proof” that the vaccine is a socialist plot to encourage American girls to have sex. The FDA said:

Healthcare providers and consumers should be aware that syncope (fainting) may occur following vaccination with Gardasil, sometimes resulting in falling and traumatic injuries.

Right on cue, the American Chronicle dressed that up as:

… they have to admit that a faint followed by tonic-clonic movement and seizure like activity, which ever way they dress it up, is really saying in the broad sense, a child could have a ‘Grand Mal Seizure’ after having a Gardasil vaccination. Many girls have gone on to be diagnosed as epileptic after having Gardasil vaccines.

“In the broad sense … Many girls have gone on to be diagnosed as epileptic after having Gardasil vaccines”? Really, American Chronicle, really?

BNET spent some time in October trying to debunk the idea that Gardasil is in some way dangerous. Let’s update that information to see just how ravaged America’s fragile female youth has been by this fainting epidemic that the liberal media conspiracy is refusing to cover. The CDC:

As of May 1, 2009, more than 24 million doses of Gardasil were distributed in the United States.

As of May 1, 2009, there were 13,758 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 93% were reports of events considered to be non-serious, and 7% were reports of events considered to be serious.

And the FDA:

Of all of the reports in VAERS pertaining to Gardasil, approximately 13% describe syncope.  The percentage is similar to reports of syncope for other adolescent vaccines.

Do the math: 13 percent of 13,758 adverse events = 1,788 girls.

There are three shots to complete a Gardasil vaccine, so divide 24 million by three and get 8 million. Of those 8 million girls, just 1,788 fainted. That’s 0.02 percent — or 2 in 10,000 — who faint when getting the jab.

Now ask yourself: If you line up a bunch of giddy 13-year-old girls for an injection that has something to do with sex, cancer and genitial warts, would you expect more or fewer than 2 in 10,000 to faint during the process?

A true cynic — employed by Merck! — might argue that the fainting rate is so low that Gardasil contains some sort of anti-fainting protection, based on these numbers.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

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    tba123

    06/15/09 | Report as spam

    RE: FDA Says Gardasil May Cause Fainting; The Stats Say It Doesn't

    I think the key statement supporting your argument is this: The percentage is similar to reports of syncope for other adolescent vaccines.

    My crude calculation with updated vaers data is that the fraction of reports mentioning syncope is ~ 15% (2271 cases mentioning both gardasil and syncope vs. 15087 cases mentioning gardasil).

    e.g., see here: http://www.fdable.com/vaers/advanced_query/5017f219b458

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