Thursday, April 16, 2009

One Click for Jenny: Gardasil Question Leads to Plea for Overhauling VAERS

So here’s the thing. We can trust in the safety of the HPV vaccine Gardasil—even though it was tested for only a relatively short time before hitting the market—because the government is monitoring it, right?

Sorry. VAERS, a.k.a. the Vaccine Adverse Event Reporting System, is very far from infallible. And one little personal blog, Jenny’s Journey, has proved that by outperforming it.

Jenny Tetlock developed a mysterious paralysis shortly after receiving the Gardasil vaccine. Despite extensive testing no-one could determine whether she was being rapidly killed by ALS or by an autoimmune disease that mimicked ALS. Jenny died last month, less than two years later, at the shatteringly young age of 15.

Jenny’s parents, although cautious about flinging the blame on Gardasil, had asked VAERS to investigate the possibility that Gardasil could have triggered Jenny’s condition. The mighty VAERS system came up with absolutely no comparables, and thus decided that a link was virtually impossible. A neurologist did later independently discover a possible comparable buried in the system; however there was insufficient contact information for verification.

Upstart site Jenny’s Journey, the Tetlock's personal blogsite, came up with two strong comparables. Two strong comparables that had up until then gone unreported to VAERS because the girls’ parents and doctors hadn’t even considered that their unusually rapidly progressing ALS could be connected to their recent Gardasil shots. And sadly, there's a real possibility that if a small and under-publicized site could find those two girls, there could well be even more.

We’re all busy people, so in case you have no time or inclination to read further, I’ll cut to the chase before describing the limits of VAERS: please go to to sign a petition to get the “dinosaur” VAERS system overhauled. Regardless of whether you’re a Gardasil enthusiast, a no-vaccines-ever parent, or you’re simply concerned about making sure that vaccines “for the public good” are just as good as they can be, please check out the petition. It’s important. We need to fix VAERS.

Why is VAERS So Inadequate?

For one thing, it’s totally voluntary and poorly advertised. Although parents, pharmacists, doctors and patients may all fill out the forms, it is estimated that perhaps ten percent of all side effects and adverse events are actually reported.

First, you’d have to connect the dots, perhaps days or weeks or even months after the event—something that is often difficult, particularly at a stressful time. Then you’d have to know what to do. Although parents are typically given a vaccine information sheet that includes the VAERS website and phone numbers at the time of their child’s shot, most don’t read it, tossing it immediately because they don’t expect a serious reaction. If they do get to the VAERS website, it can be cumbersome and confusing.

“I know the family of a young lady who just died of a debilitating neural disorder, possibly triggered by the Gardasil vaccine. Their attempts to use the Vaccine Adverse Events Reporting System were deeply disappointing,” commented one signer of the petition.

Doctors, already overloaded with paperwork and red tape, don't often tap into the system. Those that do use it report that it ain’t easy. Two comments from the petition:

“Improvement of the VAER is exactly the type of step we should be taking to allow technology to improve patient care, not harm it. I fully support the efforts of OneClickOneLife to harness technology to improve this vastly outdated system. As a practicing physician I have found it tremendously cumbersome to report any adverse effect of any drug therapy which is not only unfortunate but unconscionable given the technology that now exists.”

“I am an employee in the health care field whom has completed the VAERS form. It is not user friendly, complete in all needed documentation and is out dated.”

And something doctors don’t like to discuss: it’s not easy to admit that the vaccine you’ve advocated and administered may be causing problems. Many parents ask pediatricians, “Would you give it to YOUR child?” We’re almost always confidently told “of course!”

Furthermore, doctors, researchers, scientists and even pharmaceutical executives are only human. Dr. John Colquhoun, Auckland’s principal dental officer in the 80s, came to regret strenuously advocating the fluoridation of Auckland’s water while ignoring evidence that dental decay was already rapidly declining. Whether or not you’re a fan of fluoride, his conclusion is interesting.

“I now know that what my colleagues and I were doing is what the history of science shows all professionals do when their pet theory is confronted by disconcerting new evidence: they bend over backwards to explain away the new evidence,” he wrote. “They try very hard to keep their theory intact—especially so if their own professional reputations depend on maintaining that theory.”

Complete and Accurate?

And then there’s accuracy. Perhaps because of the archaic nature of the reporting system, many reports don’t have enough information for follow-up or verification; others are simply erroneous.

Deborah Kotz, who has written several thoughtful and informative articles about Gardasil for US News and World Reports, noted that Chris Tarsell’s sudden death after receiving a Gardasil shot was wrongly reported to VAERS. Her doctor informed VAERS that the autopsy found that Chris had died of “an inflammation of the spleen caused by a life-threatening virus.” Although some minor inflammation of the spleen had been found, the report had in fact concluded that the death was due to "cardiac arrest, cause undetermined."

There’s also jumping-to-conclusions-itis—something that the Tetlocks have tried hard to avoid. Parents hear that there are concerns about Gardasil, say, and immediately assume that any little thing is connected to the shots. While over-reporting is to my mind infinitely preferable to under-reporting, it can overload and confuse the system.


Several comments on the petition highlight the lack of follow-up. One would think that if one reported a serious adverse effect, the FDA would be on your doorstep shortly; apparently one could well be wrong.

VAERS data should eventually get to the Clinical Immunization Safety Assessment (CISA) Network, a national network of six medical research centers with expertise in immunization safety which research immunization-associated health issues. But those particular mills appear to grind exceeding slow, and unless there is an unmistakable pattern with significant numbers of individuals affected, adverse events will be dismissed as “unlikely connections”. And the Vaccine Safety Data Link, developed in conjunction with several large HMOS, tracks vaccines but doesn’t necessarily connect dots with cases such as Jenny’s.

According to Kotz, the CDC is now finally investigating the three related cases of ALS and has acknowledged that the question of ALS triggered by a vaccine has occurred before, when military personnel were vaccinated against anthrax. CDC officials don’t believe there’s a link, however, but also acknowledged that the media is essential to getting the word out about vaccine issues and encouraging doctors to file reports. Oy vey. While I’m glad that reporters like Kotz are paying attention and following up, shouldn’t a tax dollar or two be spared for that?

Should Wal-Mart take Over VAERS?

Again and again I hear and read complaints about the sheer incompetence of the VAERS system. It’s enough to make me wonder whether Wal-Mart should take it over.

After all, if Wally World’s incredibly creepy information and tracking system is sensitive enough to send Pop-Tarts to soon-to-be hurricane-ravaged towns in an instant, wouldn’t it be infinitely more useful tracking and analyzing information that could save lives? It notoriously did a better job than our government after Hurricane Katrina. And Wally World sure seems to know how to get people’s attention.

OK, I’m Finished Now…

…but again, please go to to sign the petition to bring our creaking VAERS system into the 21st century.

I strongly believe that vaccinations save lives, but I just as strongly believe that there are things about them that we don’t know yet. If VAERS can help to identify small patterns, not just large ones, that can help identify those people who ought not to get vaccinations because of, say, a family history of autoimmune disease, shouldn’t we make sure that it does so?And if your child has been vaccinated with Gardasil, follow through and insist that your doctor does the same by reporting on any side effects or adverse events at:

Vaccine Adverse Event Reporting System (VAERS) – A government program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). – Quick 5 minute, anonymous Gardasil survey. RateADrug is a community site for sharing experiences and learning about risks and benefits of prescription medications and alternative treatments. Post comments and view other people’s experiences with Gardasil.

National Vaccine Information Center (NVIC) –Long questionnaire. This is a non-profit organization that advocates vaccine safety and preventing vaccine injury through education.

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