Glad we passed on the Gardasil vaccine

[lsyorke]

I would like to read Dr. Harper's complete original comments and not ones that were cherry picked possibly out of context to support the newspaper's position. I had HPV and I had cervical cancer. Yes, "current treatment" did save me, but believe me when I say that I would have preferred to have a vaccination rather than losing a very large chunk of my cervix. So much of my cervix is missing that I was put on bedrest when I was pregnant with my DD because they were afraid that it was going to open spontaneously and I would lose my daughter. I still intend on giving my DD the vaccine when she is older.

Two other sources that quote her:

http://www.cbsnews.com/stories/2009/08/19/cbsnews_investigates/main5253431.shtml

http://www.medscape.com/viewarticle/578110

 

[Geoff_M]

And people wonder why there is so little faith in vaccines.....this is the perfect example of why!

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:

"Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment."

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.

"Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

...

Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination."

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.

 

[Plannin'Shannon]

Although I myself have declined this vaccine for personal reasons, I think its important to remember how many people have received this vaccine. 15,000 adverse affects may seem like a lot, but a lot of girls have received this vaccine without a problem. There are adverse affects with any vaccine...

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...

 

[Winnie23]

I work in GYN surgery and have seen too many 30- somethings die of cervical cancer caused by HPV......it is horrible. Had this vaccine been around years ago, some of these young girls may still be alive. I have two girls that one day will be vaccinated.

 

[DianeV]

Both my daughters got the vaccine and had absolutely no problems. I would rather do anything I can to prevent any kind of cancer etc

 

[Pennykay]

Have you ever searched the VAERS data base? Search under vaccine type and symptoms "Death". It is shocking to see how many come up for Gardasil. Sad.

http://wonder.cdc.gov/vaers.html

 

[N.Bailey]

Well, after the doctor said he recommended it, I allowed my daughter to take both doses of the vaccine. I guess I can only hope that there are no long term repercussions for those who received it.

My daughter suffered no side effects either time, so I hope it ends there.

 

[AndyLL]

As the lead researcher, she would have had to sign off on the results. Why is she just coming forward now?

I think that it is very likely that her comments say more about her personal politics than they do about the vaccine.

She didn't. :

http://www.badscience.net/2009/10/jabs-as-bad-as-the-cancer/

“I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a ‘controversial drug’. I did not ‘hit out’ – I was contacted by the press for facts. And this was not an exclusive interview.”​

 

[Geoff_M]

Have you ever searched the VAERS data base? Search under vaccine type and symptoms "Death". It is shocking to see how many come up for Gardasil. Sad.

http://wonder.cdc.gov/vaers.html

Sad, yes... but you cannot just look at the raw number of reports in the VAERS database and use them to draw conclusions or imply cause. As noted in the postlicensure safety surveillance study published two months ago, when looking at the number of reported deaths after 23 million doses that occurred some time after receiving the vaccine and comparing those numbers to the death rates in other populations, the number of reported deaths were at, or below, what would be considered "normal" for that group. In another words, there appears to be no incremental deaths that can be attributed to the administration of Gardasil at this point in time.

 

[PatsMom]

I would like to read Dr. Harper's complete original comments and not ones that were cherry picked possibly out of context to support the newspaper's position. I had HPV and I had cervical cancer. Yes, "current treatment" did save me, but believe me when I say that I would have preferred to have a vaccination rather than losing a very large chunk of my cervix. So much of my cervix is missing that I was put on bedrest when I was pregnant with my DD because they were afraid that it was going to open spontaneously and I would lose my daughter. I still intend on giving my DD the vaccine when she is older.

I also lost a big chunk of my cervix to cancer. "Current treatment" did save me as well but a shot would have been much better than the surgery. And issues with pregnancy and delivery.

My daughter got the vaccine. She participated in the decision to have it. As a cervical cancer survivor, anything I can do to spare her having to deal with it is a good thing as far as I am concerned.

 

[patsal]

DD had the series of 3 shots when she was 12. She had no adverse affects.

 

[NHdisneylover]

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...

My daughter is another one. She had the 3 shot series begining the week after her 11th birthday (as recomended by her doctor--was a year "early" because she is a greade ahead in school and the district looked at grade level, not age in their requirenments). She did not even have pain at the injection site. I watched my mom fight (and win) a battle with cervical cancer. She had to have a complete hysterectomy at a young age and could never had otehr children. They do believe her cancer was caused by HPV. I am glad I could lower the risk of my DD going through what her grandmother did.

 

[MrsPete]

Well, I'm as liberal as they come and don't see vaccine safety as a "political" issue.
This is purely about the effectiveness or ineffectiveness of a vaccine, and the risks associated with them.

I'm about as Conservative as they come, and I also don't see this as a political issue. Instead, this is a medical question. If my daughters have this vaccine, WILL THEY BE SAFER? That is the only question that matters.

 

[Mellie2162]

My dd is another one who got the series of 3 about 2 years ago, she's 15 now. She did not have any adverse reactions and I hope she continues to stay healthy.

 

[Geoff_M]

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.

 

[BibbidiBobbidiBOO]

DD is 14 and she has not got it yet. Still waiting and reading. She is in on the discussions, which have been good.

She DID get the H1N1 mist , so I am not an antivaxer. Just not comfortable with this one at this time. She got Menactra at age 12.

 

[HM]

My DD is 14 and we're still in the deciding stages.

 

[MaryAnnDVC]

Both DDs got the shots, no side effects.

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 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 one (with the number of reported cases):
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!!!

Interesting perspective. Thanks!

 

[The Mystery Machine]

My 18yodd got the shots and she did have the dizziness, almost passing out side effect after each injection. She decided that she wanted to get it.

My younger dd is 13 and I will wait until she is almost 18 as well to decide if she wants the shot or not.

 

[chisnpeke]

I got the vaccine when I was 17 and got follow ups in the months after. I got the first shot with two other shots and I got a terrible sick headache afterward but that might have been because I got so many shots at once. The other two times I didn't have any adverse reactions other than a sore arm.