Tuesday, April 28, 2009

Double-Speak in Spain over Gardasil Convulsions

According to Reuters América Latina, Spain’s Agencia Española del Medicamento y Productos Sanitarios (AEMPS) and Europe’s Agencia Europea de Medicamentos (EMEA) have cleared Gardasil for take-off.

The two organizations have shrugged off any possibility that the continuing convulsions suffered by two young girls in Valencia, and by a third girl in the Balearic Islands, could be related to Gardasil. All the girls started convulsing and lost consciousness within hours of being injected with the anti-HPV vaccine. A few days later the entire batch of Gardasil was withdrawn, and although Spain’s vaccination program resumed shortly, its Ministry of Health convened a panel of experts to look into the matter.

The two girls in Valencia, at least, have suffered repeated and debilitating bouts of convulsions and have been rushed to Intensive Care several times. Experts are at a loss to explain or cure the problem and the families are, understandably, distraught and angry. Little is known about the third girl, whose case was far less widely publicized.

The two panels found no biological link between the girls’ convulsions and the shot, largely because they could find no similar cases in Spain despite the large number of vaccines given. They did, however, note that administration of the vaccine could well have “precipitated” the illness—in other words, it acted as a trigger.

That confuses me. Isn’t that a link?

According to VAERS (the Vaccine Adverse Event Reporting System) 359 cases of convulsions and 13 cases of epilepsy post-Gardasil have been reported in the U.S. to date—always bearing in mind that VAERS is a purely voluntary system and suffers acutely from both over-reporting and under-reporting.

If it were me investigating the relationship between Gardasil and convulsions, I’d certainly want to look into possible trigger mechanisms. It is distressing to see that the people entrusted with public health are willing to say that, statistically-speaking, of course there is no connection— “just” a potential trigger.

But heck, I’m just the parent of a potential statistic.


Anonymous said...

I actually get ~600 cases of convulsion
(see here: http://www.fdable.com/vaers/advanced_query/51392d26f207)

and 86 for epilepsy
(see here: http://www.fdable.com/vaers/advanced_query/c3bce96a8dc4)

data are from vaers, but this includes non-domestic data as well.

NIna said...

Hi Kirsten,

My 19 year old daughter developed epilepsy since being vaccinated. Her first seizure occured 5 days after her first gardasil shot. Her second and third seizures about 20 days after he second shot of Gardasil. she suffered additional seizures on two more occassions since and takes 1500mlg. of seizure medication daily. I reported her events to VAERS but they list only the first event and at that, list it as SYNCOPE. Her second and third seizures are not listed at all on her VAERS report. I am highly suspect that anyone is really analyzing any of the data. Thank you for your insightful blog.

Kristin Johns said...
This comment has been removed by the author.
Kristin Johns said...

Yep, the overall data on convulsions following vaccination with Gardasil worldwide (as opposed to within the US) is actually up to 603. While I was back in the database I also looked up convulsions following ALL vaccines in the USA. The grand total was 8,197; given that Gardasil is such a new vaccine and that both kids and adults get so many vaccinations now, it seems to be associated very disproportionately with convulsions.

However, I'm curious to find out whether vaccination in general has been studied much as a trigger of convulsions and/or epilepsy. A very quick search turned up info that in 72% of cases of epilepsy the cause is unknown, and "Some controversy arose a few years ago over the possibility that the DTP (diphtheria-tetanus-pertussis) vaccine might trigger epilepsy or other neurologic diseases. Some research suggests that children who have neurologic events following their DTP shot already have a preexisting impairment such as epilepsy, which is revealed, but not caused by, the vaccine." (NYT)

Hmm. I'll have to look up that controversy and find out what the OTHER research showed when I have time. Not much about convulsions, apart from febrile convulsions, however.

Nina, I'm assuming that your daughter previously showed no signs of epilepsy, right?

Speaking as someone who is in general not opposed to vaccination, I'm not sure what to think about all this. Would I withold ALL vaccinations from my kids because of the fear that they might "reveal," ie trigger, convulsions? Probably not. But as always, it comes down to risk v. reward, and I'm still of the opinion that for us, Gardasil ain't worth it.

Nina said...

No, my daughter never showed signs of epilepsy until last June...5 days after her first shot, she had her first seizure. An intersting tid-bit I'd like to add is the comparison study done by the NVIC comparing the adverse events between Gardasil and Menactra----have you seen it? If not, please visit www.nvic.org and take a look. Anyway, one of the more chilling stats from that report is trips to the ER are 30x's more likely with Gardasil than Menactra...and that stat lives at my house. I have 3 kids who went to the doctor last June 16. All 3 got Menactra and my eldest daughter also got Gardasil. She's the only one of my kids to end up in the ER 5 days later.

I am haunted by the fact that I didn't stop and think about my duaghter's risk for HPV and/or cervical cancer before I had her receive the vaccine. I got duped by Merck's slick campaign.

Thanks for this blog Kirsten. It's the best.

Kristin Johns said...

Hi Nina,

Yes, I've seen the Menctra v Gardasil report-interesting.

I forgot to ask; did you file your own VAERS report about the epilepsy? You do not need to rely on your doctor to do that. Also, did you contact Merck directly?

But don't beat yourself up about getting your daughter the vaccination. Just think how many parents wish they'd never handed their kid the keys to the car, or signed that waiver for a rock-climbing trip, or let them date that kid who (turns out) introduced them to heroin. Twenty years down the pike, I might (God forbid) be wishing I'd got the kids Gardasil.

As parents we all do the best we can to protect our kids but still help them grow in every way. Sometimes the universe just plays some cruel tricks. We aren't psychic. We simply have to deal with it all with as much grace as we can.

I often think of my friend who has twice fought off a very nasty form of breast cancer and now works for Gilda's Club. She says (and so do many of the cancer survivors I know) that while she wouldn't have chosen to have cancer, it opened her life to unexpected joy and living fully. Occasionally, when I remember, I try to do that too.

Nina said...

Yes, I filed a VAERS report. However, I re-submitted the information after seeing innacuracies in my daughter's report online. It's been about 5 weeks since I re-sent the info but I'v heard nothing.

Yes, I contacted Merck. What a joke! It was like calling tech support for my computer. The only snipet of info I was given was a verification that a report existed for my daughter. The person I spoke with told me only doctors and health professionals can speak with Merck's staff regarding individual reports. My peds office confirmed they were contacted by Merck regarding my daughter. But that was joke too...aside from administering the shots, none of my daughter's adverse events happened there. Has anyone called me? NO!

In my humble opinion, the reporting process for vaccine adverse events is a crock. I did my part and reported my daughter's events to any and all interested parties.(Doctor's Office, Merck, Sanofli-Pastuer) The only response I got, was from the NVIC. So, when I read or see a news report that states Merck, CDC and FDA are following up all events, I roll my eyes. If they are following up, I sure haven't seen it. I believe the powers at be are more focused on down-playing the adverse events than they are any thing else. It would be so refreshing for someone from Merck or the CDC, to be brave enough to briefly consider the adverse events instead of spinning them into something they're not. Pap smears have been doing a fine job thus far in the war against cervical cancer...an important detail Merck omitted from the 'choose to be one less' campaign.