Gardasil Side Effects Prompt CDC Study

[WillYourVoteBCounted]

The Center for Disease Control study - determine if pattern linking Gardasil & side effects

CDC working on Gardasil study Tuesday, August 12, 2008

There are new concerns about a vaccine given to millions of teenage girls.

Gardasil is supposed to prevent certain types of cervical cancer, but since the drug hit the market 2 1/2 years ago, there's been an alarming number of serious adverse reactions and even deaths. According to a federal tracking system, there have been more than 9,700 adverse reactions following the vaccination and 21 reported deaths since 2006.

Merck, the maker of Gardasil, points out that there is no evidence that the vaccine caused or contributed to those events.
Officials at the Centers for Disease Control say the majority of the 8 million girls who have received the vaccine have had no problems.

The CDC says it's working on a comprehensive study which will determine whether there is a pattern linking Gardasil to some of these serious side effects. That study is expected to be released in October.

What is VAERS?

The FDA says VAERS' primary purpose... is to serve as an early warning or signaling system

The information collected into the VAERS database comes from a wide array of sources, including patients and parents, state health agencies, pharmacies, health care providers, and the makers of the vaccines. Although complete information greatly enhances the analysis of vaccine safety, in order to capture as many reports as possible, reports with less complete information will be included in the database.

The primary purpose for maintaining the database is to serve as an early warning or signaling system for adverse events not detected during pre-market testing. In addition, the National Childhood Vaccine Injury Act of 1986 (NCVIA) requires health care providers and vaccine manufacturers to report to the DHHS specific adverse events following the administration of those vaccines outlined in the Act.
A balance must be struck in reducing the burden on voluntary reporters while providing enough data to produce necessary "signal flags" to trigger analysis of potential significant events and trends.

Only about 10% of the side effects reported to VAERS, numbers could be much higher

News Inferno reports: "However, a study in the New England Journal of Medicine found that clinicians, patients and drug companies report only about 10 percent of side effects to VAERS, so the actual number of Gardasil side effects could be much higher."

[Warpy]

1. Uh, every drug or vaccine that goes into wide release

is studied by the CDC for the first few years after its release.

Often, serious adverse reactions aren't fully known until it is in wide release. Even reported deaths during trials have been dismissed as flukes if there was no direct link to the product.

Remember Zomax? I was on it for 8 months, felt like I'd died and gone to heaven. Then it started killing people who kept going on and off it, something that wasn't picked up in limited trials because in those trials, people kept taking it instead of going on and off it.

Personally, I like restricting my own drugs to the ones that are old enough to be generic, but sometimes there is simply no substitute.

In that case, risk vs. benefit has to be considered carefully. All drugs are targeted poisons and should never be taken for silly reasons like "I saw it on TV."

Vaccines are different. I would hate to be a parent watching my daughter die at 30 because I had succumbed to alarmism over a vaccine that might have prevented her cancer 20 years earlier.

However, the CDC will keep collecting data. They always do.

[pnwmom]

3. You made a lot of sense until you got to: "Vaccines are different."

Why shouldn't parents and the manufacturers and the CDC be just as cautious about new vaccines as they should be about new drugs?

[Celebration]

5. I don't get that either--

Daughters can get pap smears, too.

[DemExpat]

9. Agreed. I survived cervical cancer with successful treatment

following a Pap test, and I would NOT have my young daughter take this vaccine at this time.

I do educate my children about sexually transmitted diseases, testing, and treatments.

DemEx

[pnwmom]

30. I have another friend in your situation who made the same decision. n/t

[Warpy]

15. If you are too ignorant to believe in the germ theory of disease

then by all means, avoid vaccinations.

The Darwin Award page will eventually honor you.

[pnwmom]

31. Why do you always resort to personal insults? It doesn't add anything to the

logic of your arguments. In fact, it weakens them.

[trotsky]

42. Because vaccines and drugs are two entirely different types of treatment.

If you can't understand the difference between them, you really shouldn't be participating in discussions about either.

[pnwmom]

44. I understand the difference between them. But if you can't understand the

difference between a vaccine that is fast-tracked in the approval process -- as Gardasil was -- and one that isn't, then you shouldn't be participating in these discussions.

And you certainly shouldn't have been advocating for mandating the use of Gardasil in YOUNG GIRLS when the research that was used to fast track the vaccine was conducted in ADULT WOMEN.

Also, you've previously identified yourself as a pharma person. You probably shouldn't post here about this subject unless you re-state your connection to the industry.

Here is my connection -- my baby sister died as a result of a known (but long covered up) encephalitis reaction to the old DTP vaccine. Later, I spent years as a member of a university I.R.B.
So that's my bias. I think all parents need to give fully informed consent to the treatment of their children, whether with vaccines, drugs, or tests.

[trotsky]

45. A "pharma person"?

What the hell is that?

I have absolutely NO connection to ANY pharmaceutical company, and your insinuation otherwise is pathetic and reveals volumes about the weakness of your arguments.

[pnwmom]

47. I'm sorry to have confused you with another poster.

There is a frequent poster on these issues who has identified himself in a non-vaccine thread as a pharma person, and that person's screen name is similar to yours. Still, I shouldn't have made the mistake and I apologize.

[trotsky]

50. Thank you for the apology.

And I am sorry for what happened to your sister. However no one has ever said, nor can anyone ever promise, that there will be no negative side effects from vaccination. We can certainly work to reduce them, and I strongly support such efforts, but a cost-benefit calculation will always be required. If the vaccine saves 1,000,000 lives but costs 1, is that worth it? If it saves 1000 lives but costs 1, is it still? Where's the cutoff?

[pnwmom]

52. I don't know what the cost-benefit calculation would be.

I only know that the whole process should be as open, informed, and accurate as possible.

And it's hard for me to believe that the Bush era FDA has escaped all the incompetent leadership shown by the rest of his administration.

[trotsky]

55. Well, try and take a stab at it.

100,000,000 lives saved for 1 lost. Acceptable to you or not?
10,000,000 lives saved for 1 lost. Acceptable to you or not?
1,000,000 lives saved for 1 lost. Acceptable to you or not?
100,000 lives saved for 1 lost. Acceptable to you or not?
10,000 lives saved for 1 lost. Acceptable to you or not?
1000 lives saved for 1 lost. Acceptable to you or not?
100 lives saved for 1 lost. Acceptable to you or not?
10 lives saved for 1 lost. Acceptable to you or not?
2 lives saved for 1 lost. Acceptable to you or not?

Where do you fall in the spectrum?

I only know that the whole process should be as open, informed, and accurate as possible.

So, like the infamous impossible-to-nail-down definition of pornography, you know it when you see it? If you can't define what it is you want, how do you know when you get it?

[central scrutinizer]

59. This is the crux of the issue

I went to a family reunion last year and we pored over old family trees from the 1800's. Almost every family lost children to childhood diseases. One family had eight children, only three lived past age 14. But we have no memory of those times. Times when thousands and thousands of children died every year from diseases that we have pretty much eliminated due to vaccination programs. Since we do not remember those thousands who died, and can only estimate how many would die if the vaccinations somehow vanished, we focus on what we can count: the ones who were vaccinated and suffered side effects or death. Nor will we ever be able to determine how many women will be spared from getting cervical cancer 30 years from now because of Gardasil today. No vaccine or medicine is 100% safe, but neither is crossing the street or flying in an airplane. Certainly it is tragic if someone you love dies from anything other than old age, but we take many risks every day. My daughter, who was 16 at the time, was first in line to get Gardasil. I did as much research as I could and was convinced that it was as safe as most other vaccines.

[beam me up scottie]

60. "...can only estimate how many would die if the vaccinations somehow vanished"

Outstanding post! :applause:

[pnwmom]

65. When your own sister was the life lost, and one (or more) of your children

could have been the next one, how can you make that calculation? I'm not a computer. Perhaps you are.

I can tell you when the process is NOT open, informed, and accurate. When a mandate is being pushed by a drug company who stands to profit. When a lobbyist for the pharma company works for the Texas governor who tries to mandate it. When the parents who are being pushed to allow their daughters to have the vaccine aren't informed that the vaccine was fast-tracked and that the research on young girls had not yet begun.

[trotsky]

68. You're missing the point.

If your sister hadn't been the one, her chances were pretty good to be one of the million who would have died without the vaccine. And so on.

But I'm not going to argue with you on this anymore - your emotions are what's driving your position, so no amount of reasoning will matter. I'm not discounting your emotions, only pointing out why this is fruitless. You might also do well to avoid vaccination threads, since all it seems to do is open an old wound.

[pnwmom]

71. What a laugh. I'm sure you'd rather I stay out of these threads, but not

because you care that this might open old wounds.

[trotsky]

72. When all you have to bring up is that you lost a sibling,

you're using it as some kind of trump card. That's not a nice way to treat your sister's death. You act as if your opinions are enough, because they're backed with your one experience. You won't offer details, you won't offer substance, you just play that card over and over. Again, I'm sorry for your loss, but you're not debating or discussing, you're stating an opinion totally unsupported by facts and expecting emotion to carry the day.

[pnwmom]

73. I've offered specific details. You choose to ignore them.

I've also offered specific details about the approval and attempted mandate of the Gardasil vaccine, but you're just an echo chamber for Big Pharma.

You like to throw around statistics and pretend that real people aren't involved in these numbers. I'm reminding people that drugs and vaccines that are released or mandated prematurely can injure real people.

[trotsky]

79. No, you've offered precious few specifics.

And when that doesn't work, you use your trump card. There is no one in this forum - NO ONE - who thinks that pharmaceuticals are all about sunshine and rainbows and looking out for our best interests. Your bogus charges of being an "echo chamber" down to your false accusation that I somehow had ties with them are not arguments, they have nothing to do with the topic at hand. But you use them anyway because your arguments can't stand on their own.

[Hannah Bell]

82. 4000 women die/yr from cc, most over 40.

at least 1/3 of those deaths from viri not protected with the vaccine, so make it 2800 deaths.

CC is very treatable: 75% survival.

Incidence of HPV 16 & 18 in the population: 3.4%

incidence of CC: declining - 2-6%/yr, depending on the population studied.

HPV transmission risk can be reduced with condoms a/o caraggean-based lube/foam.



Why would i think it's a good idea to vaccinate 9-12 y/o's?

[beam me up scottie]

48. Vaxphobia Translation to English: Pharma Person = Paid Shill

If that one catches on we may have to add it to the Homeobonics Dictionary.

[HamdenRice]

61. And do you understand what "side effects" and "adverse reactions" are?

Are you making the stupefyingly illogical claim that because drugs are different from vaccines, vaccines can't have side effects or people can't have adverse reactions to them?

Wow!

[trotsky]

63. No, that would be your stupefyingly illogical claim.

I'm saying that side effects and adverse reactions are generally going to be due to entirely different mechanisms when it comes to drugs vs. vaccines, BECAUSE their method of treatment is so different.

Sheesh, it's as if you're stalking me. You got a link for me yet?

[babylonsister]

2. Nice to see the CDC weighing in on this. nt

[Warpy]

19. Uh, it's their JOB

They and the FDA follow all adverse events on new medications/vaccines, look for patterns, and try to determine which if any are attributable to the new medications/vaccines.

[mzmolly]

4. K and R. Diane Harper a scientist who worked on the vaccine for 20 years, warned

against giving the vax to girls as young as we are. It's a shame that Merck did not listen.

Thanks for sharing this WYVBC.

I have a feeling the study will conclude "there is no proof that Gardasil causes X?"

[Fire_Medic_Dave]

6. Numbers could also be much lower.

If the idiots wouldn't report vasovagal syncope as an adverse reaction.

David

[WillYourVoteBCounted]

7. Numbers could be lower if they didn't report seizures, paralysis, autoimmune illnesses and death

or warts on their legs and arms, or severe weight loss, rashes, blood clots, or death.

[Fire_Medic_Dave]

11. How many of the 8,000,000 have those?

[cosmik debris]

13. You're wasting your time

mzmolly has already told us how the test results will be accepted. They will not accept the results unless they confirm the worst fears of the anti-vaxers.

With out that confirmation, they will just fall back on the universal conspiracy theory.

[beam me up scottie]

8. You can see you're dealing with expert medical professionals in here.

You should just throw in the towel now! :rofl:

[WillYourVoteBCounted]

10. and Dave is upset Vioxx is off the market

thats good medicine.

[Fire_Medic_Dave]

12. I thought it could have been left on the market with a black box warning.

No need for you to deal in the facts though, since it hurts your case.

David

[Celebration]

16. Actually, I agree with you

Vioxx was a disaster because information was hidden by Merck. There are a few people that probably really needed Vioxx. My father in law was one of them. When he had to go off Vioxx he got morphine instead. Guess what happened after that?

Many, many people died because they did not know the dangers of Vioxx. So, I have a real problem with Merck over that.

But I still think it should have been left as an option, with full disclosure.

[varkam]

18. WYVBC was vaccinated against facts at an early age. eom

[WillYourVoteBCounted]

22. Varkam suffered damage to his reasoning ability due to bad vaccinations

early on. The symptoms are revealed by Varkam's inability to post his own threads supporting his
thesis.

[varkam]

37. And if I thought that your criticism meant something...

I might be offended.

[Warpy]

20. It was, actually. It was voluntarily withdrawn after Merck

realized it would be a niche drug with low sales and threw in the towel, allowing the competing Celebrex to take the whole Cox2 inhibitor market.

They're not bad drugs taken occasionally for something like dental pain, which they do a remarkably good job on. They were just bad drugs for people with chronic pain and inflammation to take every single day.

[Fire_Medic_Dave]

21. Celebrex doesn't help me at all.

Vioxx worked wonders when my back flared up. 2 or 3 days of Vioxx with Flexeril at night and I was great. Now when it flares up I have to take Naprosyn for a week with Flexeril 3 times a day and Hydrocodone to sleep usually with a few beers (DISCLAIMER: DON'T TRY THIS AT HOME).

David

[Warpy]

25. I hope you're icing that sucker, too

That's the one thing that helps me, although Flexeril is nice to knock me out for 10 hours.

It gets better a lot faster if I keep icing it.

[Fire_Medic_Dave]

26. Swimming really helps me.

I hate Flexeril, I can't get good REM sleep with it, so I wake up tired and stay tired all day. If I can swim like 4 days a week then I don't have any trouble.

David

[beam me up scottie]

14. If Dave is like the other med pros in this forum, he's sick of having his intelligence insulted.

You seem to think that access to VAERS makes you an expert and gives you the credibility to question the motives of people who know what the fuck they're talking about.

[WillYourVoteBCounted]

23. I could use the title "Doctor" while posting online, it doesn't make me one

The internet is anonymous. just because someone claims to be a medical professional
doesn't mean anything in an anonymous message forum.

[Fire_Medic_Dave]

27. Just to be clear.

I am a Fire Captain and both a Nationally Registered and State Licensed Paramedic and an Instructor in Pediatric Advanced Life Support, Advanced Cardiac Life Support and Prehospital Trauma Life Support. It's generally not wise to call other DU members liars, just so you know.

David

[WillYourVoteBCounted]

28. and you could be some 12 year old boy typing from his mothers basement

for all I know.

[cosmik debris]

29. for all you know????

It has already been shown that you don't know much!

So it would come as no surprise that you know less than expected.

[Fire_Medic_Dave]

32. and you could be Condeleeza Rice.

I think she would have acquitted herself a little better though.

David

[beam me up scottie]

34. Now you're getting into the spirit of this forum!

It's much more fun when you finally realize using logic is futile.

YOU WILL BE ASSIMILATED

[beam me up scottie]

33. Like that would convince anyone who's read your posts!

:rofl:

[pnwmom]

39. When my son had an adverse reaction to a vaccine, the doctor

refused to report it.

My son had a fever of 102 for a full week. My doctor said it couldn't be a vaccine reaction. Why? Because, according to the experts, a vaccine related fever would only last for 2 days. Therefore, according to my doctor, my son must have developed some additional (unknown) infection subsequent to the vaccine reaction.

My son screamed in pain every time he tried to nurse for that same week. That didn't get reported either -- because screaming was considered to be normal, as long as the baby didn't scream for more than 2 hours straight. Which my son never did. To top it all off, he had partial seizures several times a day during that week. None of these reactions were reported.

So (some) doctors don't report certain reactions (like my son's screaming jags) because they don't consider them serious enough to report. And they don't report other unusual reactions, because they assume the vaccine didn't cause them.

Several years later I had a new doctor, and we pieced together the family history. That's when we found out from my mother that my 6 month old sister had died of encephalitis the day after receiving the same vaccine that gave my son problems. Needless to say, he didn't have any more.

(My niece also had a reaction to the same vaccine, a fever over 105. Her doctor didn't bother to report that either. Just stopped giving her that vaccine.)

[Fire_Medic_Dave]

81. What vaccine was it?

It is possible that your son picked up another virus or infection at the doctors office. It is pretty easy to get sick in health care facilities. Did you take your son to the doctor for the seizures?

David

[varkam]

17. Love the lie in your subject line.

So, the CDC undertakes a study to determine if the events in VAERS are linked to the vaccine, but yet you already assume that they are before the CDC investigation.

Since when is that okay? Oh, wait, I forgot, you don't need to be honest when the Truth(tm) is on your side.

[WillYourVoteBCounted]

24. you just love lies

period.

[beam me up scottie]

35. Thank you for making them so accessible.

varkam really has his plate full lately.

[WillYourVoteBCounted]

36. perhaps you or he should start your own thread - oh maybe Gardasil really does suck and you can't!

Could the problem be that:

some people have no original thoughts, hence they flock onto any threads others have posted,
or
the Gardasil vaccine IS a scam, and you cannot write an OP about the vaccine.

Whats the matter, Gardasil really does suck and you can't defend it in your own thread?

[varkam]

38. Oh? Since when have you had an "original thought"?

I'm just curious.

[beam me up scottie]

40. Original? You have eight separate anti-vaccination threads on the first page of this forum.

And your "points" have been refuted time and time again, so you'll have to forgive me for thinking that logic and facts wouldn't have an effect on these irrational rants.

[conscious evolution]

41. And you are assuming they are not

Sorry,better to be on the safe side.You know,the part of the Hippocratic Oath where it says do nothing to harm the patient?

[varkam]

56. So you're saying we are justified in flat-out assuming that they are? eom

Perhaps you should write the CDC. I'm sure all those docs need a refresher on the Hippocratic oath.

But are you saying that we should never, ever test a new medicine? I mean, after all, it might have side effects.

[trotsky]

57. If you want to get technical, ANY vaccine violates the "old" Hippocratic Oath.

You're introducing the small likelihood of harm from the vaccine in order to prevent a possible infection by a deadly disease.

Thankfully medical professionals and disease experts make these decisions.

There's a modern version of the oath that is more appropriate for an era with the medical discoveries we've made.

From http://www.pbs.org/wgbh/nova/doctors/oath_modern.html

Hippocratic Oath—Modern Version

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.

I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.


Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.

[pnwmom]

46. There are untold numbers of adverse effects that never get reported because

a doctor somewhere decides they aren't vaccine reactions. Too bad we have no way of determining those numbers.

Back in my innocent days (when I was just trusting my doctor and the standard vaccine recommendations for my babies), my second child had an untoward reaction to the DTP. He had a fever of 102 that lasted a week. Also, he screamed every time he tried to nurse for that week, and he had partial seizures several times a day. None of these reactions would have excluded him from further vaccines, according to my doctor. (He would have needed a temperature above 105 and crying lasting two full hours or more. Screaming for a half hour several times a day didn't count.)

My doctor refused to file a report. He said that the vaccine itself doesn't cause reactions that last longer than two days, so my son must be sick with something else. Something that mysteriously went away without treatment.

When it was time for my son to get his next vaccine we had moved and had a new pediatrician. In the meantime, I had accidentally learned that my sister had developed encephalitis, had seizures, and died the day after her 6 month vaccines. Also, one of my mother's cousins had seizures after a DTP vaccine and was paralyzed; another died. And a niece had already been excluded from the vaccine series because she had had a fever over 105. Fortunately, my new doctor decided not to tempt fate by giving my son, or his siblings, any more of the pertussis vaccine. (The doctors of the other cousins in this generation independently made the same decision.)

So you could say my family's reactions were never proven to be caused by the DTP vaccine. But I wonder how many true vaccine reactions -- like my family's -- are never even reported.

[trotsky]

43. Why did you stop quoting from the VAERS site?

Could it be because you know this part totally destroys your alarmism?

When reporting and evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. The event may have been related to an underlying disease or condition, to drugs being taken concurrently, or may have occurred by chance shortly after a vaccine was administered.

[pnwmom]

49. It must be nice to have such confidence in the Bush-era FDA.

It's the only part of the government, amazingly, that has escaped the incompetence of the rest of the Administration.

:sarcasm:

[trotsky]

51. So you think the entire FDA is discarded at the end of a presidential administration?

And completely restaffed with political appointees and toadies?

Clinton's and Carter's FDAs supported vaccination with the same fervor as Bush I/II and Reagan's.

[pnwmom]

53. No, I don't. But the entire FEMA org wasn't disbanded, either --

and yet the same org that had been very effective under Clinton became incredibly incompetent under "Brownie." Leadership matters.

[trotsky]

54. Apples and oranges.

FEMA and the FDA are completely different organizations, staffed with completely different specialists, designed for completely different operations. Comparing them is horrible analogy.

Or are you saying that should Obama win this fall, you will trust the FDA if it continues to assert that Gardasil is safe and effective?

Can I get you to commit to that?

[chicagomd]

58. Don't hold your breath,

but an excellent question.

[pnwmom]

64. I will reserve my opinion on Gardasil until it has been out on the market

for several more years and until the studies on girls (which weren't done prior to approval) have been completed and analyzed. Even then, we won't know about long term effectiveness.

[trotsky]

66. I'm having trouble keeping your position straight.

So you're now saying that it's NOT because Bush is president that you distrust the FDA?

Or that you trust them, just not on this issue, and/or not right now?

Again I note that you have no specifics. You just don't like it. If you don't know what you want, you'll have no idea when you get it.

[pnwmom]

67. I'm assuming that Bush won't be the President after January.

And that Obama will.

If the new President is a Bush clone, then all bets are off.

[Liberal Veteran]

62. You do realize the FDA has no authority in the 99 other countries it is approved in?

I can buy into the notion that the FDA is corrupt or incompetent. But how do you explain Canada, UK, Denmark, France, Australia, Germany, Sweden....etc?

Are we supposed to assume it's a GLOBAL conspiracy?

[xchrom]

69. i suspect a lot of the adverse reactions are phony.

the anti-vax movement is like a contagion itself -- full of outright lies and manipulation of peoples fears.

sure sounds like anti-women and children right wingers to me.

and btw -- gardasil works better than expected and protects against vaginal lesions that were not expected.

HPV vaccines
Vaccines are being developed to prevent HPV infection.  There are many different HPV strains.  Some are known to be high risk for cervical cancer.  If we had effective vaccines against all these strains, we might be able to prevent cervical cancer altogether.  Several research trials have been testing vaccines as a way of preventing infection with HPV.
A trial testing Gardasil called FUTURE II reported its results in October 2005.  This phase 3 trial involved over 12,000 women aged between 16 and 26.  These women did not have HPV before the start of the trial.  The women were divided into two groups.  Half the women were given Gardasil and the other half had a dummy vaccine (placebo).  Both groups of women had 3 injections of either the vaccine or placebo over six months.  Over the following two years the women had regular checks to see if they had developed HPV, or had any precancerous changes to the cells of the cervix, which could develop into a cancer.  The group who had the vaccine showed no precancerous changes.  Of the 5,258 women who had the placebo, 21 had precancerous changes, which is 0.4%.  The researchers found that Gardasil protected against HPV types 6 and 11, as well as 16 and 18.  Gardasil was licensed for use within the European Union in September 2006.  
Two other phase 3 trials have tested the vaccine Cervarix.  The first was for women under 26 and closed in July 2005.  It involved over 18,000 women from all over the world, including the UK.  This study was called ‘PATRICIA’ (PApilloma TRIal to prevent Cervical cancer In young Adults).   The second was for women of 26 and over, and closed in August 2006.  The aim of the trial is to find out the effect of the Cervarix vaccine on long term HPV infection. So it will be some time before we know the results.
It is possible that these vaccines will be used in a national vaccination programme in the UK in the future.  The research suggests that they would dramatically lower the number of cases of cervical cancer.  They would also reduce the need for colposcopy.  At the moment, they are only available on private prescription.  There is more information about HPV vaccines and cervical cancer in the cervical cancer questions and answers section of CancerHelp UK.
http://www.cancerhelp.org.uk/help/default_printer_friend.asp?page=9596

merck is not the only company who developed this vaccine -- a french drug company was also the developer

Comparable strategies needed to evaluate human papillomavirus vaccine efficiency across Europe

K Soldan1 ([e-mail]), J Dillner2

1Health Protection Agency Centre for Infections, London, United Kingdom
2Dept of Medical Microbiology, MAS University Hospital, Lund University, Malmö, Sweden
A quadrivalent vaccine against human papillomavirus (HPV) types 16, 18, 6 and 11, known as GardasilTM (or Silgard, see note) was granted a marketing license by the European Commission in September 2006 following the positive opinion of the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use in July 2006 <1>.

HPV infection is the most frequent sexually transmitted infection in Europe. Certain HPV types have been established as causative agents of cervical cancer (and its precursor stages that are the target of cervical screening), as well as of some other rare cancers of the ano-genital tract and oral cavity. A meta-analysis of published studies found just over 70% of invasive cervical cancer cases in Europe to be positive for HPV types 16 or 18 <2>. Pre-cancerous stages of cervical disease are common and often resolve with time. However, their follow-up, including treatment, repeated screening and examination of the cervix (colposcopy), is associated with considerable costs and anxiety. HPV 6 and 11 are not causally linked to cervical cancer, but are associated with some low-grade cervical lesions, the vast majority of genital warts and the rare condition of recurrent respiratory papillomatosis <3>.

The Gardasil vaccine is composed of virus-like particles (VLP) generated by the synthesis and self-assembly of the major HPV capsid protein (L1) in yeast cells (Saccharomyces cerevisiae). Gardasil has been licensed for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3), cervical cancer, high-grade vulvar intraepithelial neoplasia (VIN grades 2 and 3), and external genital warts (condyloma acuminata) causally associated with HPV types 6, 11, 16, and 18 <1>. Trials have been undertaken to demonstrate the efficacy of the vaccine in women aged 16 to 26 years and immunogenicity in girls and boys aged 9 to 15 years. Protective efficacy in males has not been reported in the literature yet, but the results of more trials involving males are expected over the next few years.

Another vaccine composed of virus-like particles (VLP), a bivalent vaccine for HPV 16 and 18, manufactured by GlaxoSmithKline, is currently under evaluation by the EMEA. Both these prophylactic vaccines have been shown to have very high efficacy in uninfected women against infection, cervical intraepithelial neoplasia and, by implication, against cervical cancer caused by the HPV types targeted by the vaccine <4>.

The availability of efficacious vaccines now means that vaccination strategies should be designed and evaluated to inform decisions on efficient control of HPV-related diseases. Several questions about HPV vaccination efficacy and effectiveness are still under consideration <5> For example, data on its efficacy against disease in males and in women aged over 26 years (of whom many could have been previously infected) are still awaited. A longer follow-up of vaccine programmes is needed to determine the duration of protection. The impact of vaccination on the epidemiology and disease burden of HPV types not covered by the vaccine is also uncertain. There are some data from trials which suggest cross-protection against HPV-types closely related to the vaccine types. The possibility of type-replacement with non-vaccine types emerging as the cause of more disease is also a concern to be evaluated further. It is likely that most European countries will first consider vaccination of girls who have not yet become sexually active
http://www.eurosurveillance.org/ew/2006/061123.asp

regarding the stigma around hpv --
Social Stigma
 
"There is unfortunately a social stigma associated with cervical cancer because HPV is a direct cause in approximately 70% of cases," Dr. Makhija told Medscape. "People are under the impression that this means the patient slept around or was in some way more sexually active, but this is often not the case, and she may well have been with 1 person who had the infection."
 
HPV is the most common sexually transmitted infection in the US. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with HPV every year and that over half of all sexually active men and women become infected at some time in their lives.
 
"Our expectation is that the far-right machine will gear up its disinformation and fearmongering tactics, all aimed at reducing availability of the vaccine by threatening funding and clouding the facts regarding the safety and the need for this vaccine," Ms. Julie Kay, an attorney for Legal Momentum, a New York City–based women's-rights organization, said in a statement to the press.
 
But Dr. Makhija said she has been pleasantly surprised by reaction so far. "I think people are realizing that this is not a political issue so much as a health issue." Based in Alabama, the investigator had worried about how difficult it might be to recruit women in the Deep South for the trial. "But we enjoyed an enormous response and had no trouble at all," she said. "People realized that this is something that could potentially protect their daughters, and the response has been excellent."
 
"Exciting Win Against Cancer"
 
Mr. Alan Kaye, from the National Cervical Cancer Coalition in Van Nuys, California, called the news "an exciting win against cancer." He is looking forward to what this could mean for public health.
 
But he is also glad from a personal perspective. Mr. Kaye founded the cancer coalition with his wife before she died of cancer. Today is the 5-year anniversary of her death. "It's wonderful to think that this amazing step forward has taken place on such an important day," he said. "My wife would be pleased."
 
http://www.brodstonehospital.org/your%20health.htm

other countries approve gardasil --
During an interview with Medscape, Jaime de la Garza, MD, from the Instituto Nacional de Cancerología in Tlapan, Mexico, agreed that the vaccines represent an important advance. He says they will be especially important for women in developing countries. "The incidence of cervical cancer is continuing to rise, and mortality rates are especially high in poor countries. If we can get vaccines such as these to patients, it will make a big difference."
 
Gardasil was approved last week for use in Mexico and is currently under review with regulatory agencies in the European Union, Argentina, Australia, Brazil, New Zealand, Singapore, and Taiwan.
http://www.brodstonehospital.org/your%20health.htm

this from an interview with dr tristram in the uk

Dr Tristram said, "This vaccine has to be given as a preventative, before there is any contact with the virus.


"If we are looking at the population and asking who should be vaccinated, we have to consider that one in four young people are sexually active before the age of 16, so we have to look at a younger age group.


"Another issue to consider is that, at around the time of puberty, if the cervix comes into contact with HPV, it is more likely to cause problems."

more --

Q Will the vaccine replace the need for regular smear tests?


A Dr Tristram said, "Cervical screening has been very successful in reducing the incidence of cervical cancer and this should not stop just because a vaccine has been introduced.


"There are lots of different types of HPV which can cause cervical cancer, not just 16 and 18, for which the current vaccine offers protection.


"The vaccine will reduce the incidence of cervical cancer further, but it will not get rid of it."

it also looks like some hpv related cancers are becoming MORE virulent and difficult to treat.

meps' in the uk supporting the use of gardasil

glynis wilmot is the labour mep for the west midlands

Cutting cancer deaths

I reported in the October edition that European Commission had licensed Gardasil, the first vaccine against HPV which can lead to cervical cancer. 

I am pressing the Commission on its plans to ensure that vaccination programmes are introduced in all member states, as well as a comprehensive programme of education to inform parents about the vaccine. Immunising every 12 year old girl could cut deaths from cervical cancer by more than 75%.

Latest information

http://www.gleniswillmott.labour.co.uk/ViewPage.cfm?Page=20338

planned parenthood's statement on gardasil

 Planned Parenthood Applauds FDA Approval of Gardasil
HPV Vaccine Is Crucial Step Forward for Women's Health  

New York, NY — Planned Parenthood Federation of America (PPFA) commended today's action by the U.S. Food and Drug Administration (FDA), which approved the first vaccine against two types of human papilloma virus (HPV) that cause about 70 percent of cervical cancer cases. 

"This is a huge step forward for women’s health.  Prevention is the key to good health, and this vaccine will give future generations the promise of health, safety and peace of mind," said PPFA President Cecile Richards.  “Now we must move forward to educate the public about the vaccine and ensure it is available to all Americans, regardless of their income level.” 

Planned Parenthood provides more than 1,000,000 women with cancer screenings each year.  This new vaccine will hopefully save lives. 

"The HPV vaccine is a public health breakthrough," said Richards.  "On behalf of the millions of women, men and teens Planned Parenthood serves every year, I thank the FDA for today's action." 

Worldwide, cervical cancer is the second leading cause of cancer deaths among women.  Each year approximately 10,000 cases of cervical cancer are diagnosed in the United States, and 4,000 American women die from the disease.    

###
http://ww1.ppgi.org/includes/media/prjune_06_c.asp

canada approves gardasil{ but of course merck has subverted the entire world to it's sinister plans}
HPV VACCINE APPROVED

In July 2006, a new vaccine to prevent against four strains of the Human Papilloma Virus was approved for use in Canada by Health Canada. Gardasil will be available by the end of August 2006 through Canadian physicians and pharmacists, and is designed to prevent cervical, vulvar, and vaginal cancer as well as genital warts.

For more information, please visit: http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm.
http://www.optionsforsexualhealth.org/

[varkam]

74. Oh, you and your "facts"

You're just a bought-and-paid for shill, and you know it!

:sarcasm:

[WillYourVoteBCounted]

75. If you believe that, then read this Peace Activist/Epidemiologists letter about Gardasil AND Merck

Read Andy Silver's

"How soon you have forgotten."
http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x39359

Andy is a long time peace activist and protestor, a member of an organization for peace for Israel and Palestine, a key member of an anti torture group.

Andy has been protesting war for decades. He is also an epidemiologist.

Read what he says before you assume that people who don't trust this vaccine, or people who don't trust the FDA or Merck - are right wingers or anti sex.

[xchrom]

77. what the fuck -- you gotta be kiddin -- this is so far from

evidence that the spoon running away with the fork is more believeable.

please please try to get in the realm of real plausiblility -- it' s people s lives here we're talking about not your paranoid wishful thinking that could get people killed.

[xchrom]

70. ...

http://www.ajmc.com/Article.cfm?Menu=1&ID=3083
the american journal of managed care
Another example comes from Sanders et al, who used decision analysis to assess the cost effectiveness of a potential vaccine for human papillomavirus (HPV) as a way to prevent cervical neoplasms. Cervical cancer is one of the most common malignancies in women, diagnosed in about 13 000 women per year and responsible for the death of about 4000 women per year.35

Researchers built a decision tree to evaluate length of life and cost for vaccinating adolescent girls against high-risk types of HPV. The target population was all adolescent girls in the United States, with a base case of 12-year-old girls (sexual activity before age 12 is considered rare). This assumption was tested in a sensitivity analysis.

The analysis assumed universal vaccination, although during the sensitivity analyses the researchers did evaluate the cost effectiveness of targeting only high-risk girls. The model included data on incidence of HPV infection; low-versus high-risk HPV types; rates of HPV progression; cancer surveillance, treatment, and progression; benign hysterectomy (assuming such women were protected from cervical cancer); HPV vaccine characteristics; and the effects of HPV infection and cervical cancer on quality of life and costs.

The researchers found that although a prophylactic vaccine against high-risk HPV types was more expensive than current practice, it resulted in greater quality-adjusted life expectancy. They predicted that such vaccination would avoid more than 224 255 cases of HPV; 112 710 cases of squamous intraepithelial lesion, a precancerous condition; 3317 cases of cervical cancer; and 1340 deaths related to those cancers. Their sensitivity analyses found the vaccine would be cost effective, even assuming booster shots every 3 years and an efficacy as low as 40%.35

[WillYourVoteBCounted]

76. we need a study to find out why some girls get sick from the Gardasil Vaccine

and the other vaccine, Ceravix or some other meds/not vacs may be safer and have more promise.

But Gardasil is hurting some girls who otherwise would have been healthy and happy.

[xchrom]

78. considering anti-vaxers make outrageous shit up --

that is a ridiculous statement on your part.

phyllis schlalfly at eagle forum will glad to know you are doing her work for her.

[trotsky]

80. You don't have any facts to support this statement:

Gardasil is hurting some girls who otherwise would have been healthy and happy.

You are basing this assertion on raw VAERS data, when the FAQ itself says:

Are all events reported to VAERS caused by vaccinations?

No. VAERS receives reports of many events that occur after immunization. Some of these events may occur coincidentally following vaccination, while others may truly be caused by vaccination. Studies help determine if there is more than a temporal (time) association between immunization and adverse events. The fact that an adverse event occurred following immunization is not conclusive evidence that the event was caused by a vaccine. Factors such as medical history and other medications given near the time of the vaccination must be examined to determine if they could have caused the adverse event. It is important to remember that many adverse events reported to VAERS may not be caused by vaccines.

This has been pointed out to you again and again and again, but you ignore it. Your crusade against the vaccine is severely weakened by your demonstrated lack of understanding of the facts.

[Hannah Bell]

83. Cost-effective for who?

The prediction is 1340 deaths will be avoided with universal vaccination & booster shots every 3 years.


This is idiocy of the highest water.