Glad we passed on the Gardasil vaccine

[claudia]

Not to veer into dangerous political territory, but the source of the article is a right wing conservative online publication. And we know how Conservatives feel about a vaccine for the prevention of a STD.

Just sayin'...

well...here's one from CBS:
http://www.cbsnews.com/stories/2009/02/06/eveningnews/main4781658.shtml

 

[Took]

This isn't a political thing, this is a researcher stating her opinions on a vaccine that she worked on.

which does not mean that it isn't politically motivated....sad but true.

My DD received the shot and had not ill effects. I don't regret the decision a bit. Dr. Harper may be out to get the pharm company; we don't know what her motivation is now. She could, of course, be right on and be telling us things we need to know. Time will tell.

 

[Took]

Here's a prime example of how taking adverse reporting data at face value can lead you down a blind alley. I looked at the FDA's adverse reporting data for April to June, 2009. Unfortunately, the FDA doesn't have a nice on-line query system like the CDC does for vaccines. But you can download the raw data here and build your own Access database, if you'd like.

For the quarter covering April-June, 2009 I looked at adverse reports for Advil. After looking at the raw data, I can't believe that anyone would take this highly dangerous product. Nor can I believe that the FDA allows it to be sold! In three month alone there were over 3,000 reported adverse reactions (in 715 different categories) to the common OTC pain-killer Advil. Here are a list of some on the more severe ones (with the number of reported cases) that were associated with taking Advil:
Amnesia, 3
Anorexia, 10
Autoimmune Hepatitis, 6
Cardiac Failure, 2
Cardiac Failure Congestive, 19
Cardiac Murmur, 14
Cellulitis, 13
Collapse of Lung, 6
Crohn's Disease, 17
Depression, 37
Hepatitis, 13
Jaundice, 10
Multi-organ failure, 2
Pneunomia, 15
Pulmonary Embolism, 11
Suicidal Behavior, 2
Suicidal Ideation, 20
Suicide Attempt, 11
etc.,etc.,etc.

And this is covers only 90 days of reporting!!!

I think you can debate if the vaccine is cost-effective. I think you can debate if it's better over other forms of monitoring and treatment. I think you can debate whether HPV is a "life-style issue". I think you can debate if it's over-marketed. But I think the "unsafe" gambit isn't holding any real water at this point.

Thank you! I teach this sort of fact finding and analysis of numbers as part of a research class. Numbers alone don't tell the whole story. And the original article did not give an absolutely accurate picture of all this Dr. Harper said. It was biased.

 

[Rora]

OP- thanks for posting the link.

I did not receive this shot and I'm glad I did not. To each his own.

 

[Geoff_M]

From the CBS story:

"The National Vaccine Information Center, a private vaccine-safety group,..."

Calling the NVIC a "vaccine-safety group" is like calling The Minute Men a "border safety group". They are firmly an anti-vaccine group. If a vaccine were developed to prevent autism, I'm sure these guys would be against it.

Three points about the NVIC's "analysis":
1) They cherry picked their data. Why did they only compare Gardasil to ONE other vaccine instead of all vaccines given in that age range? The likely answer: It gave them the negative comparison they were wanting. If you look at the NVIC's site, I'm sure you'll find that they aren't too wild about Menactra either.
2) Were the differences between Gardasil and Menactra because Gardasil is "worse than average" or that Menactra is "much better than average"? You can't tell from the "analysis".
3) The recently published CDC postlicensure study that I mentioned in this thread looked at ALL the VAERS data, and not just a slice of it, and found that with the exception of two issues (and apparently not alarmingly so), all of the things that the NVIC "flagged" were within the expected "norms".

 

[rie'smom]

My daughter is not a number. Statistics can be quoted all day long. She did not and will not get the vaccine. I'm hoping for those girls/women who have received it that there are no side effects discovered down the line.
The lead researcher is saying these things. And as far as politics, isn't it mostly the hippie go la la granola parents who refuse to have their kids vaccinated? I'm in the middle of the road-liberal in some areas and conservative in others.

 

[shortbun]

I quickly read the article and I find it interesting that a doctor who works for the World Health Organization would back up her statement about NOT needing mass vacinnation by saying that four out of five women with cervical cancer are in developing countries. Also, she says cervical cancer is not that prevalent yet I know several women, including my sister and my best friend, that have had parts of their cervix removed because of it and are not able to have children. I do not have a daughter so maybe it's not even for me to say but when I heard about this vaccine I thought, 'it's about time!' Better hope your daughter's intimate partners are as wise as your daughters. Oh, and those boys may have had relationships with a girl who dated a boy who slept with a girl...

 

[rie'smom]

I quickly read the article and I find it interesting that a doctor who works for the World Health Organization would back up her statement about NOT needing mass vacinnation by saying that four out of five women with cervical cancer are in developing countries. Also, she says cervical cancer is not that prevalent yet I know several women, including my sister and my best friend, that have had parts of their cervix removed because of it and are not able to have children. I do not have a daughter so maybe it's not even for me to say but when I heard about this vaccine I thought, 'it's about time!' Better hope your daughter's intimate partners are as wise as your daughters. Oh, and those boys may have had relationships with a girl who dated a boy who slept with a girl...

It could be heredity. I only know 1 person who had cervical cancer. My great aunt was diagnosed with it when she was 80.

 

[lsyorke]

But I think the "unsafe" gambit isn't holding any real water at this point.

I don't believe that the original post even mentioned "unsafe"...this is about effectiveness of the vaccine, which is in question and has to be since it's use is so new.

As for the VAERS reporting, yes, everything gets reported and doesn't definitively determine causation. BUT, if those reports are discounted(which they very often are) then where does one go for actual long term use information? As it stands now, the only long term use studies are done by the company that makes the product. The VAERS reports have long been thought to be underreported(about 10% of the drug reactions) more than overreported.

A drugs effects and risks only come to light when a drug is released to the general population, so to dismiss the reports to the VAER is missing a very important collection of information.

 

[luvmy3]

If there are no efficacy trials for girls under 16, what is it they are basing their recommendation for kids as young as 9 to get this vaccine? If it is merely the fact that these girls will one day be older and sexually active then IMO it can wait. My dd could get pregnant too when she's sexually active it doesn't mean I should start giving her BC pills now at the age of 12.

 

[Geoff_M]

I don't believe that the original post even mentioned "unsafe"...this is about effectiveness of the vaccine, which is in question and has to be since it's use is so new.

The article linked by the OP clearly raises the safety spectre, quotes Dr. Harper as saying "There also is not enough evidence gathered on side effects to know that safety is not an issue." The author then goes on say that girls and women are learning "the hard way" about the safety of Gardasil and then lists a litany of maladies from the VAERS much in the same way I did with Advil.

As for the VAERS reporting, yes, everything gets reported and doesn't definitively determine causation. BUT, if those reports are discounted(which they very often are) then where does one go for actual long term use information?

No one is arguing that the reports be "discounted", except when it can be shown that the rates aren't meaningfully different than what you'd find on average. Otherwise, you'd have to agree that taking Advil is associated with cardiac failure, depression, and suicide and people are learning "the hard way" about the safety of that product. Want I'm saying is that until the reported rates of adverse reactions rises above the "normal" background noise, you can't start connecting the dots.

As it stands now, the only long term use studies are done by the company that makes the product. The VAERS reports have long been thought to be underreported(about 10% of the drug reactions) more than overreported.

Well, unless you're going to say that under-reporting is unique to Gardasil, then the other baselines would be similarly effected too, so that'd be a moot point. I also hope you aren't saying that the suicidal tendencies from taking Advil is really 10 times worse than currently reported!

It's also worth noting that with adverse reporting going paper-less and on now the web, it's taken off big time... particularly with consumers.

Got an adverse reaction to report: here you go!

A drugs effects and risks only come to light when a drug is released to the general population, so to dismiss the reports to the VAER is missing a very important collection of information.

Again, I'm not saying that things like the VAERS and the AERS aren't valuable... they are. And from time to time, things DO pop to the surface through the background and are brought to the attention of the medical community and regulators.

 

[robinb]

My dd could get pregnant too when she's sexually active it doesn't mean I should start giving her BC pills now at the age of 12.

Yes ... but how many teen pregnancies are there where the parents had no idea that their child was sexually active? I believe that the recommendation for the vaccine at a younger age is to make sure that it is already protecting against HPV when kids finally do become sexually active.

 

[Geoff_M]

If there are no efficacy trials for girls under 16, what is it they are basing their recommendation for kids as young as 9 to get this vaccine?

A better question might be "Is there any reason to think, medically, that the immune system of a 9 year-old would react differently to the vaccine than that of a 16-year old?"

 

[DVC Sadie]

Well I wish I had had the opportunity to receive this vaccine before I received a type 3 diagnosis which led to a early hysterectomy while still in my childbearing years.

 

[luvmy3]

A better question might be "Is there any reason to think, medically, that the immune system of a 9 year-old would react differently to the vaccine than that of a 16-year old?"

Not for me or my dd

I am not anti-vax, my dd recieved Menactra and will be getting the H1N1 when its available. The issue I have with Gardasil is that a 9 year old is more at risk for adverse reactions from the vaccine than they are for HPV. At 16 the risk for HPV becomes greater due to the fact that they are most likely sexually active, therefore changing those odds. My decision is about weighing the risks, and right now since my 11 year old is not sexually active, the only risk that is posed to her is the unknown (and some known) effects of the vaccine, which is why at this age she will not be getting it.

 

[robinb]

A better question might be "Is there any reason to think, medically, that the immune system of a 9 year-old would react differently to the vaccine than that of a 16-year old?"

Plus, the time period needed for the study of 11-year olds would be pretty long. It would take many years for those girls to become sexually active and be tested for HPV. Girls that are 16 are much closer to being sexually active (if they are not already having sex) and the time needed to test the efficacy of the vaccine is less. The girls in the trails are not lab rats. It's not like they expose them to HPV and see if they become infected. They have to track the natural rate of infection with the vaccine v/s those girls who do not have the vaccine.

 

[MinnieMe87]

I'm one of them. I received the vaccine when I was 18, and didn't have one single side effect.

Simply offering a personal experience...

Me too!

 

[dismom2]

I would hope that after Merck's problems with Vioxx you wouldn't say "And people wonder why there is so little faith in medicines!"

Gardasil, being a new vaccine I think bares worth watching and closer examination. I also don't know about the exact incremental benefit that it offers. But, I'd also like to see some back-up to what Dr. Harper had to say on the matter.

However, I did notice a couple of things about the article:This comment by the author of the story is just plain silly. There's no basis to believe that their will just be a continual linear reduction of the number of cervical cancer cases over 60 years until they become extinguished totally. Instead, you can expect that as some point the reductions will slow and then likely reach a "floor" somewhere above zero unless there is some other medical breakthrough.
Scary stuff, I must say! However, the VAERS system is a self-reporting system where anyone can file a report of anything that happened that they think might be connected to the vaccine. If two weeks after I get a shot and I forget my wallet on my way to work, I can fill out a report with the VAERS system that I think that the vaccine triggered "memory loss". Bingo, by law it has to go into the system as I report it. And reporters and critics can use it to imply that the vaccine causes memory loss and some people "learn the hard way" about it by not being able to buy lunch at work.

But of course "dropping dead" is a pretty definite result and is a lot worse than having to bum $10 off of a co-worker. Dr. Harper's concern of the lack of pre-approval testing may be genuine, but it's good for us that the CDC and FDA performs periodic postlicensure safety surveillance studies on vaccines and drugs. These studies use reported "adverse events" in the VAERS and other adverse reporting systems, and compare these results with the rates of like events in the normal population. In August 2009, the results of the first postlicensure safety surveillance study of Gardasil were published in the JAMA. The study covers adverse events reported from June, 2006 to the end of 2008. During that time over 23 million doses of the vaccine where administered. The summary is posted here. The findings? With the exceptions of "syncope" (fainting, 8.2 reports per 100,000 doses) and "venous thromboembolic" (blood clots within the blood vessels , 1 report per 500,000 doses), the rates of all other events (including "death") were at or below the levels you'd expect to normally see in that population size over that period of time. This is a government study, using government data... but to be safe they also included adverse reports from pre-licensing studies too.

There will be more surveillance studies over time, and you can bet that they'll be watching the clot issue more closely. The reported rate was above average for what you'd expect, but apparently not high enough to be a "smoking gun". As more doses are given, we'll see if problems are confirmed (or if they fad back to expected levels) or if new things about the vaccine emerge. But based on what's been seen so far, I think that those that are hoping the vaccine will be declared "unsafe" and pulled off the market will be disappointed by the data.

As for us, we gave it to our daughter. One of my wife's cousins also died of cervical cancer as a teenager.

You must believe everything the government, and government-run agencies say; that's very naive. God help everyone when people stop searching for the truth. As for the FDA-- I have done some deep research on them in the past, and I am 100% convinced that even they cannot be trusted.

One PP mentioned that some of these 'reporting' sites could be total fraud. I understand what you are saying....there's no proof that what those people are reporting is true. However, please tell me....why would thousands of different people waste their time posting about an adverse drug effect? Tell me exactly what their motives are? What do they gain by wasting thier time making these fraudulant claims? On the contrary, big pharma, doctors (kick backs), and many others on the opposite end have a HUGE motive to convince people to use thier drugs, to convince everyone that the drugs are safe....and to advertise so strongly.... they stand to make millions....billions (or less for some people lower on the ladder, but still benefit from pushing it), from you buying thier drugs.

You know, back to what you were saying Geoff---about silly sounding side effects. Have you heard of Mirapex or Requip? They are drugs marketed for RLS (which some people also belive is not 'real', but I can assure you it is). One of the side effects/warnings listed (they are both parkinsons drugs) on these is that you could become a compulsive gambler or shopper. When I first read that I had to laugh. But, you know what? It's a very real side effect that REALLY affect a lot of people. You can laugh at it all you want, or exaggerate your 'selective' findings---which you seem to dig deep for in order to back up your agenda/opinion. I seriously wonder if you have any relation to a pharmaceutical company, or something to gain. Are you a doctor, an attorney? You sure seem to be spending a lot of time trying to convince everyone that all these different vaccines are safe---or at least, the good outweighs the bad. And you don't seem to believe anything negative you read about the drugs. If your completely healthy daughter dropped dead or got seriously ill immediately following a vaccine---especially a controvercial one (and one that had her symptoms listed as a side effect, and many, many people posted about this side effect on unregulated sites), I bet your opinion would not be so strongly pro-pharm. anymore.

Some of these people and places that you assume are trustworthy are not. If you believe that, you are very naive. Pharm companies and banks rule the world---that's how they get away with so much. It's all about politics and the almighty dollar. You think they really care about your health? And doctors do not know everything---they believe what the pharma tells them, and get kick backs from many drugs they push. A lot of people are not given what they truly need because of this.

You can beleive what you want, but I'm not going to let anyone inject me or my children with something that I am not convinced is safe.

 

[Mouse House Mama]

Great article about the lead researcher for the Gardisil vaccine. When the lead researcher makes comments about the safety of the vaccine and its overall effectiveness, one has to wonder why this thing is still being pushed.
http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt

Money.

 

[Lisa loves Pooh]

Exactly! It doesn't prevent cervical cancer... not all types of HPV, even those 4 strains, will cause cervical cancer in every women who gets it. The vaccine is preventing the HPV... there are so many factors that go into cancer development. My point is that its marketing for cervical cancer because it sounds more "appropriate" to have a vaccine for cancer prevention rather than STD prevention.

That was in the fast talk/small print after the ad--the ads were definitely produced in a manner as to imply that these moms were saving their children from cancer when it wasn't true.


I'm not a fan of drive-thru vaccine production myself and am not surprised that this is all coming out.