CDC Report Stirs Controversy For Merck's Gardasil Vaccine

CDC Report Stirs Controversy For Merck's Gardasil Vaccine
Cervical Cancer Vaccine Linked to Deaths, Incidents of Fainting and Blood Clots
By RADHA CHITALE
ABC News Medical Unit
August 18, 2009

A government report out today raises new questions about the safety of the cervical cancer vaccine Gardasil and links the drug to 32 unconfirmed deaths as well as higher incidences of fainting and blood clots than other vaccines.


Christina Tarsell, 21, died 18 days after recieving the last of three Gardasil shots. Her mother, Emily Tarsell, believes the vaccine against some strains of the human papilloma virus was responsible for her daughter's death.
(Courtesy Emily Tarsell)


Emily Tarsell started her daughter Christina on Gardasil -- a vaccine that protects against four of the most common cancer-causing strains of the human papilloma virus (HPV) -- after her first visit to a gynecologist and at the doctor's recommendation.

Eighteen days after Christina received her final vaccine shot, she died.

"I know it was the Gardasil," Tarsell said, although the official cause of death was undetermined. "They were really recommending it, saying that there weren't any side effects, that it was safe. So I kind of went against my better instinct {and let her} get the shot."

Deaths like Christina's are one of several types of complications reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) following Gardasil distribution in 2006, a summary of which appears in the Journal of the American Medical Association today. Some of these adverse events were serious, including blood clots and neurological disorders, and some were non-life threatening side effects from the vaccine, including fainting, nausea and fever.

Although experts agree that the accuracy of data from VAERS reports -- which can be made by anyone and are not verified or controlled for quality -- is questionable, they remain divided as to whether extreme adverse events, which are serious but rare, are cause enough to stop recommending and administering the Gardasil vaccine without further investigation.

Report Shows Rare But Serious Side Effects May Result From Gardasil Vaccine

"Although the number of serious adverse events is small and rare, they are real and cannot be overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients," said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri. "The rate of serious adverse events is greater than the incidence rate of cervical cancer."

more...

http://abcnews.go.com/Health/CancerPreventionAndTreatment/story?id=8356717

for eight - ten years. Rare complications occur with most medical interventions, but I'd like to know what the possibilities are BEFOREHAND and not make my child a guinea pig.

of the pharmaceutical companies for making and selling harmful products. They are the prescription provider for my secondary health insurance which dispenses my prescriptions. Once I let them pressure me into taking a drug called Prinivil for my blood pressure. It was supposed to be identical to Zestril, which was a medication I was already taking and tolerating nicely. Merck told me that Prinivil was a generic for Zestril and that I would save money.

I switched and almost immediately began having shortness of breath, chest pains and headaches. If I tried to stand up quickly I was woozy, and it didn't control my blood pressure as well as the Zestril. I told my doctor about it and she said that at that time there was no generic for Zestril, and to stop taking the Prinivil. The adverse side effects were too severe and she had heard of them before.

When I contacted Merck to ask to switch back to Zestril they wouldn't do it. They told me that they had no way of knowing if I was really having side effects or not. I had to buy some Zestril out of pocket and the pharmacist told me that Prinivil was a proprietary drug produced by Merck, not a generic for anything. I had not been getting a price break as they had promised, so I contacted them again and told them what I had found out and demanded to know what they were doing. Merck said that they made Prinivil, so it was a price break for them to dispense it instead of Zestril. They continued to refuse the Zestril, though there was no contractual basis for them to do so. The contract said which medication I took was up to me, as long as it was prescribed by my doctor.

I called my doctor and asked if she could help me, and she wrote Merck a rather hostile letter which caused them to reverse their stand so that I could get my Zestril back. I will not knowingly use any medication or vaccine created by Merck. I think they are among the worst of the worst.

on young women in Africa yet, the vaccine is marketed in Western countries.

Either she died from the vaccine or she died from other causes. Young people die all the time from many causes not related to medication.

round three of the vaccine makes it suspect, and so they used her as a salient example. Since I've been paying attention to these types of claims, where there's been smoke there has usually been fire. Even the use of silicon in breast implants, though "proven" not to cause problems, has been discontinued in favor of the use of a saline solution. I have been prescribed two drugs in the last ten years which were subsequently pulled off the market because of documented heart-related side effects, some of which resulted in death. Clinical trials are not infallible and it seems that lately they've been faulty more often than is acceptable IMHO.

You assert that the timing is significant, but this assertion absolutely requires us to examine other potential factors. At present, we know that she is (sadly) dead and that she received the vaccine, but we have no basis for assuming a causal link. Even if she died as a result of the vaccine, we still need to determine whether it due to a bad batch, a bad dose, a general flaw in the vaccine, or to some other factor unique to her situation.


Incidentally, silicon implants have not been discontinued, and insofar as they have fallen out of favor, it's been due to public perception rather than to sound science.

SiliconeImplant Recall

Breast augmentation studies and research since this time have been conducted because of serious safety concerns regarding breast implants. As women began reporting numerous local complications after breast augmentation, experts and consumers began to request information by way of breast augmentation studies and research. In 1992 silicone implants were pulled from the market after serious concerns about local complications, particularly implant rupture and its adverse consequences. After this recall and the numerous reports of illness and injury from silicone implant patients, medical organizations began to conduct comprehensive breast augmentation studies and research to learn more about the safety of breast implants. (...)

Re-instating Silicone Implants

Recent breast augmentation studies and research have focused on silicone breast implants once again. Two major US implant manufacturers have been aggressively pushing for FDA approval on cohesive silicone breast implants which have been banned for 12 years. The company Mentor received conditional approval in July 2005 to begin marketing their implants, while Inamed is still working to gain FDA approval on their silicone implants.

http://www.aboardcertifiedplasticsurgeonresource.com/breast_augmentation/augmentation_studies.html

I took an antidepressant that was later discontinued (uncertain of recall) due to connections with tumors. The doctor at that time persuaded me not to use St. Johns Wort due to 'connections with tumors'.

That's the important statement.

Of those who have been indoctrinated into the "All Vaccines are always good" meme.

Risk to benefit is a decent consideration. Based on the numbers of chuildren who contracted polio before the vaccinations were available, I feared polio. So my offspring had a polio shot.

But many of the other shots had a very poor risk to benefit ration. And if the risk outweights the benefit, why take the risk?

When the risk outweighs the benefit, it is simply Un-scientific to take that risk.

were called naive when this first came up, but it seems that time has confirmed our fears. A major member of Big Pharma spends megabucks to get something brand new made mandatory, that always gets my suspicions up.

I figure that six-eight months from now, we're going to be reading all kinds of similar horror stories about the H1N1 vaccine, and reading about very few deaths due to the disease itself.

for a doctor to assert that ANY pharmaceutical has "no side effects".
If that was indeed the case as the mother reports, there was some serious malpractice.

sexually transmitted virus that can and does cause cancer -- this will go little remarked:

'Although experts agree that the accuracy of data from VAERS reports -- which can be made by anyone and are not verified or controlled for quality -- is questionable, they remain divided as to whether extreme adverse events, which are serious but rare, are cause enough to stop recommending and administering the Gardasil vaccine without further investigation.'

vaccines like this are under constant review -- they have to be -- here, in the eu, etc -- reports like the death of this young lady are taken very seriously. but they also have to be provable. -- and to some of you this vaccine was tested in the u.s., th eu among other places.

right now vaccines like gardasil actually work better than what was initially expected.

How dare we not push our daughters off a cliff and cheat Mercke out of their 300-400$ per
girl?

:eyes:

lets attack people who disagree, call their comments piffle, ok?
Cause you have nothing else.

The reason that your post is piffle is not because I disagree with it but because you're invoking irrelevant--and in at least one case baseless--examples to suggest that Gardasil is in some way part of a large, ongoing pattern.

I disagree with it because it is piffle; not the other way around.

underscores the miserable state of health/science reporting. Nothing like ratcheting up the fear with misinformation - plenty of DUers love to do it too.

"Eighteen days after Christina received her final vaccine shot, she died."

Have them determine a different cause of death.

avoid many diseases in a safer fashion than play guinea pig.

I understand the fear that this strikes in the hearts of parents but as I said these events are quite uncommon and the reports are not thoroughly investigated. There are reports of people reporting adverse events in order to sue large drug makers as well so I would be careful with drawing a conclusion until there is an investigation and the stats have been compiled.

I would be skeptical and cautious until there is more information.

tell the patient that their are NO side effects?

This is what is discussed with the person receiving the vaccine or their parent or guardian before the vaccine is administered. We also have them acknowledge understanding and receipt of the VIS. (Vaccine Information Statements.)

Human Papillomavirus Vaccine - VIS http://www.cdc.gov/vaccines/Pubs/vis/downloads/vis-hpv.pdf


You can find a list of these for other vaccines here.
http://www.cdc.gov/vaccines/Pubs/vis/default.htm

It looks like any other vaccine related hand out.

and thats all we need. Very scientific.

It is a fact that we have not had adverse events with it nor have any of our 5 clinics here nor have the 22 nearby sister clinics had any reports from their patients.

When you create an argument you should base it on facts or experience. I am giving you my experience based on the facts available to me. Take it or leave it but don't create an argument that you made up in your head.


I don't see anywhere in my post where I stated adverse events don't happen to anyone. :shrug:

you tell patients to look for. That does not mean you have not had any side effects in your patients.

One girl who died after the series, stated that she had symptoms but didn't know what the cause was. Her Mother who was also unaware, kept taking her in for the shots. Unfortunately, the girl in question is dead now.

http://www.newsinferno.com/archives/5267

reactions weeks later.

:(

What with the letter leaked to the UK "Mail" about the issue of Guillaume Barre and how many people will be afflicted with it if the swine flu vaccine is used this fall.

And now this about Gardasil.

Gardasil was an entire vaccine campaign issued around a shot whose side effects were unknown. And the disease that it prevented (If it indeed did) was something that only resulted in 3,600 fatalities annually. Our teenage girls would be better protected by a campaign to keep them off their cell phones during their lifetimes as drivers.

for it gives me the creeps. Very bad juju vibes.

Much like the ones against marijuana are intended to produce. But fail.
Our society is insane.

This from a primary researcher who worked on developing the vaccine, Diane Harper. She was never comfortable with using this vaccine in young girls either.

my SIL and I were talking the other day about the vaccine recently. My niece is 12 now, and SIL was considering getting her vaccinated at some point. I told her to really think long and hard about it and that I will send her some adverse event info. I will be including this story.

Thanks for posting - I hope my SIL decides against the vaccine. :scared:

And is recommended for girls as young as NINE! That means new shots when they are 14, 19, 24!

Should I get the HPV vaccine? Does it work? Is it safe?

It depends on your age and whether or not you already have had sex.

Right now, the HPV vaccine (called Gardasil®) is only given to females aged 9 to 26. The vaccine is given in three doses (shots) over a six-month period. Women who are pregnant should not get the HPV vaccine until after the baby is born.

The HPV vaccine works best in females who haven’t been exposed to the virus. It protects against four types of HPV. Studies show the vaccine prevents about 70 percent of cervical cancers if it is given to women and girls before they have sex for the first time. It also protects against about 90 percent of genital warts. The shot works for at least five years, maybe longer. It is still under study.

The vaccine was tested on thousands of females before being approved in 2006. It was found to be safe and does not appear to cause severe side effects.
Studies are also being done on HPV vaccines for males.

http://www.womenshealth.gov/FAQ/human-papillomavirus.cfm