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scotmum

112 Posts

Posted - 09/10/2008 :  19:21:06  Show Profile  Reply with Quote
The HPV campaign rolls out from this Friday at my daughter's school. Does anyone know where the trials for this vaccine were conducted and how may women/children were involved.

Also, just how many women worldwide have received this vaccine? Any documented adverse reactions? (anecdotal or "official")

Is the package insert available on the internet?

I know that Cervarix is cheaper than Gardasil and manufactured by GSK - who have a very close relationship with the government. The waffle sent out to parents seems to be more than usually vague. (My daughter's friend was under the impression it would protect her from all types of cancer including skin cancer!)

Scotmum

GUS THE FUSS

United Kingdom
1465 Posts

Posted - 09/10/2008 :  20:39:32  Show Profile  Visit GUS THE FUSS's Homepage  Reply with Quote
Try this

http://www.jabs.org.uk/forum/topic.asp?TOPIC_ID=2336&SearchTerms=Cervarix

Also put in HPV in the JABS search at the top right of the page..

MMR RIP
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Suba

United Kingdom
396 Posts

Posted - 09/11/2008 :  10:01:48  Show Profile  Reply with Quote
NOT ENOUGH ANSWERS, TOO MUCH PROPAGANDA. LETS HAVE A REAL DEBATE WHY PARENTS SHOULD ALLOW UNKNOWN INGREDIENTS PUMPED INTO THEIR LITTLE GIRLS WITHOUT PROPER TRIALS OF THE CERVARIX VACCINE ON THE SAME AGE GROUP.
VACCINES HAVE COINCIDED IN AN AGE WITH MORE CANCER, MORE MULTIPLE SCLEROSIS, MORE DIABETES, MORE AUTISM, MORE LEARNING DIFFICULTIES, MORE ASTHMA, MORE ALLERGIES, MORE ECZEMA, MORE PHARMACEUTICAL INDUCED
DEATH, MORE PROFIT FOR THE PHARMACEUTICAL COMPANIES, MORE CORRUPTION!
ESPECIALLY WITH HPV VACCINES MORE PARALYSIS, MORE MISCARRIAGES. IN FUTURE YEARS SERIOUS CONCEPTION PROBLEMS.

InfoisPower

Another thing. Just like all the already mandated vaccines you can bet there will be no long term studies of efficacy or side effects of this one either. We and our babies will be used for scientific experimentation with only salutory oversight to protect the manufacturer's and government posteriors and not ours.

__________________

Zealous environmentalists who believe and argue that climate change is beyond debate, the science beyond interrogation, and that anyone who disagrees is no better than a Holocaust denier, are irrational.

InfoisPower

Can anyone find the ingredients to the new Gardasil (merck) or Ceravix (GSK) ? I've searched and searched.

I see that Merck applied for a BLA and blocked the lead ingredients from being publicized.

When can we find out WHAT is in that shot. We all know it's more than just water and the weakened virus.

I see that Merck's Gardasil uses a traditional alum adjuvant whereas GSK's version will be a pumped up type of adjuvant called AS04. It is a new molecule made from the aluminum salts.

Questions I'd like the answers to :
* Is the vaccine a live attenuated virus , or is it inactivated ?

* What culture did they use to grow the vaccine in ? (monkey , rabbit , dog , human fetal , etc...)

* What are the "inactive" ingredients ? (formaldehyde , thimersol , aluminum)

Jen123

Well, not too impressively, my gynecologist answered questions about ingredients with "what's thimerosal?" And she'd worked on the clinical trials for Merck!

gnu

More nutrition and cervical dysplasia
Folate:

Quote:
In a study at the University of Alabama in Birmingham, researchers compared the amount of folate in the red blood cells of 294 women with cervical dysplasia with that of women without the condition. Then they checked with the women to see whether they smoked, used oral contraceptives, had given birth or had an HPV infection. And in each case, they found that the risk factor was more likely to be associated with dysplasia if the women had low levels of folate. Women with low levels of folate who were infected with HPV, for example, were five times more likely to develop dysplasia than women who were loaded with folate.
Lycopene:

Quote:
In a study conducted at Albert Einstein College of Medicine in New York City, researchers found that lycopene, a carotenoid found in tomatoes, has a direct effect on the development of cervical dysplasia. Studies are ongoing, says Prabhudas R. Palan, Ph.D., assistant professor of obstetrics and gynecology at Albert Einstein, who is leading the study. But right now it looks as though the more tomatoes you eat, the less cervical dysplasia you get.


Vitamins A and C and some others:

Quote:
Since as far back as 1981, statistically significant differences in levels of vitamins A and C and beta carotene have been noted between women with cervical dysplasia and healthy controls (Romney SL et al 1981; Wassertheil-Smoller S et al 1981). Other nutrients studied in cervical dysplasia include folate, zinc, and vitamins B6, B12, and E. Changes in diet and nutritional supplementation can reduce the odds of developing cervical cancer (Marshall K 2003; Gagandeep et al 2003; Friedman M et al 2005).

Diet and premalignant lesions of the cervix: evidence of a protective role for folate, riboflavin, thiamin, and vitamin B12.:
Quote:
CONCLUSIONS: This investigation provides evidence that thiamin, riboflavin, folate, and vitamin B12 may play a protective role in cervical carcinogenesis.

Although I'm sure that no amount of evidence will convince someone who is determined to believe otherwise, I am posting all this information regarding the importance of nutrition in preventing cervical dysplasia and cancer for those who are actually interested in learning. It may actually help someone remain confident in their decision not to vaccinate. Much of the evidence not only shows that a diet high in certain nutrients can prevent dysplasia, but that it can also cure it. Hope it helps someone out there.


Plummeting

Quote:
Although I'm sure that no amount of evidence will convince someone who is determined to believe otherwise, I am posting all this information regarding the importance of nutrition in preventing cervical dysplasia and cancer for those who are actually interested in learning. It may actually help someone remain confident in their decision not to vaccinate. Much of the evidence not only shows that a diet high in certain nutrients can prevent dysplasia, but that it can also cure it. Hope it helps someone out there.

mamakay

I had a GYN in Miami who believed the problem is that most docs would immediately start in with the Leeps, etc., instead of waiting to see if the body would clear it on its own - he said most peoples would.

ChristinaLucia

Diet and premalignant lesions of the cervix: evidence of a protective role for folate, riboflavin, thiamin, and vitamin B12.:

Although I'm sure that no amount of evidence will convince someone who is determined to believe otherwise, I am posting all this information regarding the importance of nutrition in preventing cervical dysplasia and cancer for those who are actually interested in learning. It may actually help someone remain confident in their decision not to vaccinate. Much of the evidence not only shows that a diet high in certain nutrients can prevent dysplasia, but that it can also cure it. Hope it helps someone out there.
I am so gald to see this info; I just had a LEEP and want to ensure I don't end up having another one.

__________________
Manifested!

I came here to see if anyone has heard about the new vaccine. I just heard on the news that they are getting ready to come out with it for girls who are not yet sexually active.

(I confess I didn't read the whole thread)

I was wondering why all of the commercials and then last week I get a phone call from my hmo telling me to make sure I go to the gyno and get checked for cervical cancer because it is on the rise. I wonder if that is a marketing strategy they teamed up on???? well anyway then I hear the news and I am not at all suprised.

__________________

skyblue

Well I don't vax so I certainly understand the pov of those who oppose the vax. On the other hand I have HPV. Luckily for me my strain does not cause cervical cancer and I had only one outbreak with no further problems and that was almost 10 years ago. So HPV is not just coming around. We aren't just finding out about it. It's just that people still don't know about it. I've been participating in online communities for about 6 years now and it comes up from time to time and it's amazing how little people are aware of it. So I do see the point in the "tell some one" campaign. I think it's a good one. I don't however think I should vaccinate my infant against HPV. There has to be a middle ground.

__________________

Edited by - Suba on 09/11/2008 10:33:02
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Suba

United Kingdom
396 Posts

Posted - 09/11/2008 :  10:10:39  Show Profile  Reply with Quote
http://endofmen.wordpress.com/2008/07/20/cervical-cancer-vaccine-punted-to-300000-more-teenage-girls/

An interesting article floating around.


Side effects that occurred during clinical trials with Cervarix were as follows:

#9830; Very common (side effects which may occur in more than 1 per 10 doses of vaccine):
pain or discomfort at the injection site
redness or swelling at the injection site
headache
aching muscles, muscle tenderness or weakness (not caused by exercise)
tiredness
#9830; Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of
vaccine):
gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
itching, red skin rash, hives (urticaria)
joint pain
fever (#8805;38C)
#9830; Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000
doses of vaccine):
upper respiratory tract infection (infection of the nose, throat or trachea)
dizziness
other injection site reactions such as hard lump, tingling or numbness.

A look at Cervarix ingredients, from the same document;

The active substances are:

Human Papillomavirus1 type 16 L1 protein2,3,4 20 micrograms
Human Papillomavirus1 type 18 L1 protein2,3,4 20 micrograms

adjuvanted by AS04 containing: 3-O-desacyl-4- monophosphoryl lipid A (MPL)3 50 micrograms

adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+ in total

L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant
DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived
from the insect Trichoplusia ni.

- The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
(NaH2PO4.2 H2O) and water for injections.

Some samples from the Scientific Discussion PDF that stand out to me (as a layman, obviously);

No pharmacodynamic drug interaction studies were performed according to the Note for Guidance on Preclinical Pharmacological and Toxicological testing of vaccines (CPMP/465/95) and Guideline on Adjuvants in Vaccines for Human Use (EMEA/CHMP/VEG/134716/2004).

Studies to demonstrate absorption, distribution, metabolism, and excretion of the active ingredients in Cervarix have not been performed for any of the component viruses. This is in line with Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95).

Single-dose toxicity of the HPV-16/18 L1 VLP AS04 vaccine was assessed as part of the repeat-dose toxicity study in rabbits. The treatment was well tolerated and no treatment-related systemic effect was noticed on haematology, body-weight, clinical signs, mortality and clinical chemistry over a 14-day observation period.

According to the Note for Guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95) and the Guideline on adjuvants in vaccines for human use
(EMEA/CHMP/VEG/134716/2004) genotoxicity studies are not required for this vaccine.

According to the Note for Guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95) and the Guideline on adjuvants in vaccines for human use
(EMEA/CHMP/VEG/134716/2004) carcinogenicity studies are not required for this vaccine.

Edited by - Suba on 09/11/2008 10:24:42
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thomas p

United Kingdom
314 Posts

Posted - 09/11/2008 :  14:45:15  Show Profile  Reply with Quote
Dear Scotmum,

Here is a link to the Summary of Product Characteristics (side-effects are in section 4.8 (page 12) and you should also read sections 4.3, 4.4 and 4.5 (and 4.6 if your daughter's pregnant, although I assume that she isn't)) and the package insert (page 31) for Cervarix (pdf).
It contains the information on the ingredients and also answers your question regarding clinical trials (16,142 subjects received cervarix, whilst 13,811 received placebo).
To give this some context, in a study of 16,000 subjects receiving an active ingredient, you would expect to find events which occur at a rate of approximately 1 in 5,000.
As you can see from the SPC, during clinical trials no serious side-effects were detected, therefore it is safe to deduce that serious side-effects occur less often than 1-in-5,000.
To give you more context on cervical cancer, according to Cancer Research UK the age-adjusted rate of Cervical cancer in Scotland a couple of years ago was 10.2 per 100,000 women (or 1 in every 9,803 women). The rates are falling from over 16/100,000, presumably thanks to smear-testing.

According to wikipedia, trials were conducted in USA, Brasil, Germany & Poland, amongst other countries (I also know that some trials were undertaken in the UK too).

I don't know how many people have received Cervarix, but it went on sale in Sweden and Germany before the UK and was licensed in Australia and the phillippines before in Europe, but as far as I am aware the UK government is the first to choose Cervarix as its HPV vaccine.

So far the vaccine has been shown to be protective for 6 years (the first subjects in trials received it 6 years ago) and if they are following up for protection, then they would also have a legal obligation to monitor these people for side-effects (and to report these to the authorities).

Your implication that GSK have a particularly close relationship with the government doesn't actually bear up to scrutiny, but having read the stuff that's posted here, I am not surprised that you believe it. However, that's irrelevant because Cervarix is a Centrally Authorised Product, meaning that it was the European Commission which granted the license and the vaccine is regulated by the Committee on Human Medicinal Products, to which all EU Member States provide experts. the UK would only have 1 27th of the CHMP decision.

Sorry for the long post, but I thought it best to give you as full an answer as I could. I hope that this information is useful to you in making your decision. In case you care, if it were my daughter (and it will be in a few years), then I would, on balance, go ahead with it.
If you're still concerned that there may be further rare side-effects with the vaccine, then you could wait a few months until far more girls have received it and then pop along to your doctors later if nothing comes up (since cervarix is a new drug, GSK have to submit Periodic Safety Update Reports, containing information on every single adverse reaction reported to them every 6 months, so they'll be sending their second one in to the the authorities in a month or so and we'll know by November or December if there is a sudden rash of rare serious side-effects).
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MinorityView

USA
611 Posts

Posted - 09/11/2008 :  15:20:55  Show Profile  Visit MinorityView's Homepage  Reply with Quote
t.p. do you know if the placebo group actually got a placebo, or if they got the same vaccine with the hpv?

cause if the adjuvant causes the majority of the reactions, then the placebo ain't really a placebo.

any study of possible serotype replacement? seems unlikely that the bugs will just quietly allow themselves to be bumped if there is a nice habitat to be filled, especially as there are dozens of other hpv varieties floating around

Aged survivor of many years of alternative health care...and one vaccine, administered by a doctor without the consent of my parents, 50 years ago.
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thomas p

United Kingdom
314 Posts

Posted - 09/11/2008 :  17:43:42  Show Profile  Reply with Quote
quote:
Originally posted by MinorityView
t.p. do you know if the placebo group actually got a placebo, or if they got the same vaccine with the hpv?

If it had the HPV in then it's not a placebo, therefore it cannot have had the HPV in. People with far more expertise than me in this area will have studied the results or GMC and virological studies and much much more and the placebo will have been just that.
Did you read the SPC? Have you read anything on this which gives you cause to be suspicious that they had contaminated placebo?

quote:
Originally posted by MinorityView
cause if the adjuvant causes the majority of the reactions, then the placebo ain't really a placebo.
My emphasis. Unless you have evidence on the harm that can be caused by the microscopically small amounts of aluminium that are used as adjuvants then please state it and state why all the toxicologists are wrong to believe that the levels used are safe.
This document here provides info on number of ADRs in clinical trials with vaccine and with what I think is an aluminium containing placebo (and other placebos). If you're particularly interested then you should probably read that.

quote:
Originally posted by MinorityView
any study of possible serotype replacement? seems unlikely that the bugs will just quietly allow themselves to be bumped if there is a nice habitat to be filled, especially as there are dozens of other hpv varieties floating around
Eh? Are you implying that the placeno is simply the live vaccine with the virus removed, as opposed to the adjuvant without the vaccine put in?
I may have misunderstood you, but I think that's what you're saying. If it is, then you're dead wrong. If it's not what you're saying, then please could you explain it again for me.
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MinorityView

USA
611 Posts

Posted - 09/12/2008 :  02:23:15  Show Profile  Visit MinorityView's Homepage  Reply with Quote
Okay, for the Gardasil studies, they used a placebo containing the full amount of aluminum and compared it with the vaccine. So any reactions due to the aluminum wouldn't be spotted between the placebo group and the active group. There was a group of 300 who got a real placebo. This group was looked at separately when it came to minor reactions, but combined with the big aluminum placebo group when it came to major reactions.

On the serotype replacement bit, I'll try to explain the problem simply.

HPV, in some women, starts to cause serious problems. Most women, if exposed, can clear HPV, but not all. HPV comes in many, many varieties. Currently, a small group of these varieties cause most, but not all of the problems. The vaccine gets rid of the problematic varieties. However, all the other types of HPV are not affected in any way by the vaccine. So, after the vaccine, the HPV which hasn't been whacked, is free to adapt and start multiplying and in some women, causing problems, because there is now an empty niche in the eco-system, created by the vaccine.

This problem, called serotype replacement, has already occurred with the Hib vaccine and is developing with Prevnar.

I just wanted to know if anyone had studied the problem with HPV?

Aged survivor of many years of alternative health care...and one vaccine, administered by a doctor without the consent of my parents, 50 years ago.

Edited by - MinorityView on 09/12/2008 02:24:10
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thomas p

United Kingdom
314 Posts

Posted - 09/12/2008 :  08:59:17  Show Profile  Reply with Quote
Re: serotype replacement - thanks for explaining - since the vaccines are new, then probably not. However, it's not as though there's a cancer-shaped hole in women waiting to be filled. it's not certain that this will happen, and if it does then it'll clearly be possible to develop vaccines against the new types.

Re: placebo - If you actually read the Australian document I posted a link to @ 17:43, it gives you the cumulative numbers of ADRs to vaccine and to placebo, so you can see for yourself that it is not the case that most ADRs are due to the aluminium, so it's not a problem.
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Suba

United Kingdom
396 Posts

Posted - 09/12/2008 :  10:08:21  Show Profile  Reply with Quote
Initial tests using Gardasil, only performed on females were undertaken on 11,00 people between ages 9 and 26 worldwide and found the most common side effect was injection site pain. While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related. Now isn't that a coincidence! Guess what? Aluminium was in the placebo. Now the vaccine does not look so bad as people just drop down all the time as indicated with the placebo. The wonders of modern science!

Edited by - Suba on 09/12/2008 10:20:59
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thomas p

United Kingdom
314 Posts

Posted - 09/12/2008 :  13:33:05  Show Profile  Reply with Quote
The topic is cervarix, not gardasil.
I've provided a link to a document which addresses the placebo question relating to cervarix. If you can do adding up, then kindly do it Suba, otherwise all you're doing is speculating mindlessly (as ever).
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scotmum

112 Posts

Posted - 09/12/2008 :  15:23:07  Show Profile  Reply with Quote
Thanks for the link, Thomas P. Seem to be rather a lot of common and unpleasant side effects from this vaccine - headache, gastro-intestinal disorders, etc. No surprise then that this link isn't provided on the consent form handed out to parents.

By the way, I still believe GSK (like all large corporations) have a close relationship with the powers that be. See below........

Glaxo Exec Resigns From UK Watchdog Group
By Ed Silverman
July 9th, 2008

Paul Blackburn, a Glaxo vp and financial controller, has
reportedly left the board of Ofsted, the UK's official education
watchdog agency, amid growing controversy that his appointment reflected improper ties between the governing Labor Party and the drugmaker.

The news was disclosed on Seroxat Sufferers, a blog devoted
to chastising Glaxo over its Paxil antidepressant, which is known as
Seroxat in the UK. An Ofsted representative disclosed the change in an e-mail <http://fiddaman.blogspot.com/2008/07...ns-from-ofsted
.html> to the site. We have reached out to Ofsted and Glaxo for
comment and will update you with any reply. UPDATE: A Glaxo spokeswoman confirms Blackburn resigned amid "unfounded allegations," and stresses it was done so at the request of Ofsted.

The resignation comes one month after Blackburn was named to
the board, a move that itself occurred shortly after the government
awarded an estimated $200 million contract to Glaxo for its Cervarix HPV vaccine for school-age girls 12 years and older, which some parents fear will give a green light to teenage sex.

Blackburn's appointment also came as a growing number of UK
families are filing lawsuits against Glaxo over its antidepressent,
prompting criticism that the government conferred moral authority on
Glaxo and commercially strengthened its position at a time when children are being targeted by pharma with meds for treating ADHD, in particular. Glaxo markets Dexedrine in the US for ADHD.

Scotmum

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whatif

USA
286 Posts

Posted - 09/12/2008 :  18:47:12  Show Profile  Reply with Quote
quote:
[i]Originally posted by thomas p[/i]
[br]Re: serotype replacement - thanks for explaining - since the vaccines are new, then probably not. However, it's not as though there's a cancer-shaped hole in women waiting to be filled. it's not certain that this will happen, and if it does then it'll clearly be possible to develop vaccines against the new types.




And yet again thom p provides evidence of failure to understand many a topic that thom p the jabberwocky jabs about. Follow the flora thom p...follow the flora.

But had you been able to answer what was posed to you regarding your claim that "gardasil protects against cancer", maybe you wouldn't have made yourself out to be such an ignorant stooge. Slow down thomas...don't forget gardasil and cervarix are targeting HPV types 16 and 18. Now, why don't you review the very last post here (it's been put to you a couple of times and you're as mute as you are dumb):

http://jabs.org.uk/forum/topic.asp?TOPIC_ID=2438&whichpage=2

You would quickly figure out that gardasil's only effects were largely for grade I lesions.

Hey thom p...what's the recommended treatment for grade I lesions? Dat's they discourage treatment of this condition. In other words, monitor it while you do nada, zip, nil cuz it's not considered precancerous.

But that's beside this point. What about serotype replacement...well it looks like there's AT LEAST 15 "oncogenic" strains.

Let's repeat it again for thom p:

"Findings from the FUTURE II trial showed that the contribution of nonvaccine HPV types to overall grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ was sizable"

and

"In contrast to a plateau in the incidence of disease related to HPV types 16 and 18 among vaccinated women, the overall disease incidence regardless of HPV type continued to increase, raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18"

Huh, did you read that thom p..."overall disease incidence regardless of HPV type continued to increase"

Yup, you right thom p, gardasil protects against cancer...err...I meant squat diddly. Come on thom p, do your maths, you think cervarix is gonna be different?

Sorry, stupid question, of course you do! And you're ready to give it to your daughter. You might as well give her gardasil, it at least goes after 4 HPV virus' and all those nasty reaction reports are, of course, coincidence: duh.

P.S. it's not as though once we synthesize the vaccine for thomas p's, there will be a thomas p shaped hole left to fill. There will be some hack to fill it, but not quite as nicely as thom p did.

Edited by - whatif on 09/12/2008 19:05:00
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thomas p

United Kingdom
314 Posts

Posted - 09/12/2008 :  22:30:10  Show Profile  Reply with Quote
whatif - I hadn't seen the post you linked to - anyway, gardasil is not cervarix.
However, I've now read the article that you have cherry-picked lines from. The FUTURE trials have mostly sexually active women, and as you'll know, having read the article, it shows better efficacy for virgins - "In these [non-sexualy active] subgroups, efficacy of nearly 100% against all grades of cervical intraepithelial neoplasia and adenocarcinoma in situ related to vaccine HPV types was reported in both trials."

Regarding the serotype replacement, there's no evidence that the serotypes that filled the niche had the same oncogenicity as 16 & 18 - however they may be, we just don't know yet. If they are, then further serotypes will have vaccines developed against them and the vaccination right now will have been partly useless; however if they don't prove to be as cancerous, then not giving the vaccine would lead to lots of women getting cancer unnecessarily.
Nobody knows exactly what the future will be, but the best guess of people far more intelligent than you is that it's best to go for it.

There is indeed need for further studies, and the 2 FUTURE trials are continuing and there will certainly be even more because GSK is gonna sponsor a trial of cervarix vs gardasil. I'm sure that there will be other trials in the future and also we will be keeping a close eye on these products. The good thing, from an epidemiological perspective, is that vaccines are given by healthcare professionals so we have an excellent estimate of actual exposure so we will easily be able to estimate the incidence of an adverse events even in the general population.
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GUS THE FUSS

United Kingdom
1465 Posts

Posted - 09/12/2008 :  22:45:03  Show Profile  Visit GUS THE FUSS's Homepage  Reply with Quote
Well Dr T Pee of LT/RT tell that to the girls that will/have died more untested vaccines Whoopy Dooo!!!

wakey wakey troll
MMR RIP
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whatif

USA
286 Posts

Posted - 09/13/2008 :  01:43:12  Show Profile  Reply with Quote
quote:
[i]Originally posted by thomas p[/i]
[br]whatif - I hadn't seen the post you linked to - anyway, gardasil is not cervarix.
However, I've now read the article that you have cherry-picked lines from. The FUTURE trials have mostly sexually active women, and as you'll know, having read the article, it shows better efficacy for virgins - "In these [non-sexualy active] subgroups, efficacy of nearly 100% against all grades of cervical intraepithelial neoplasia and adenocarcinoma in situ related to vaccine HPV types was reported in both trials."

Regarding the serotype replacement, there's no evidence that the serotypes that filled the niche had the same oncogenicity as 16 & 18 - however they may be, we just don't know yet. If they are, then further serotypes will have vaccines developed against them and the vaccination right now will have been partly useless; however if they don't prove to be as cancerous, then not giving the vaccine would lead to lots of women getting cancer unnecessarily.
Nobody knows exactly what the future will be, but the best guess of people far more intelligent than you is that it's best to go for it.

There is indeed need for further studies, and the 2 FUTURE trials are continuing and there will certainly be even more because GSK is gonna sponsor a trial of cervarix vs gardasil. I'm sure that there will be other trials in the future and also we will be keeping a close eye on these products. The good thing, from an epidemiological perspective, is that vaccines are given by healthcare professionals so we have an excellent estimate of actual exposure so we will easily be able to estimate the incidence of an adverse events even in the general population.



Are you serious thom p? Excellent efficacy in virgins? Uh, excuse me, but what did you expect? And these are the people that are "far more intelligent than" me? Actually, coming from you thom p, I consider that a compliment. Are these the same people that believe the vaccine benefit outweighs a likely anaphylactic reaction to a known allergen; per your other "simple" "common sense" post? Oh, the authors of the NEJM article, and many others are seriously questioning gardasil.

But hey, you seem to think efficacy in virgins means something regarding HPV induced cervical cancer. Let's see if we can break it down for thom p? Might take a few times, but let's give it a go.

---Uh, thom p, do you think virgins are likely to have HPV creating an 'epicervical' niche (i.e. how does HPV get there)? Before you answer, give these a read:

http://www.cancer.gov/cancertopics/factsheet/risk/HPV

http://www.cancer.org/docroot/CRI/content/CRI_2_4_2X_What_are_the_risk_factors_for_cervical_cancer_8.asp

---So, to draw an analogy for thom p...it's like giving someone a measles vaccine and then quarantining them from measles sources and saying..."look they didn't get measles, the vaccine works"

---Let's try another way of saying it...according to you, "efficacy" was "demonstrated" in a group of virgins...which would have basically nil, nada, zip risk factors for HPV of the cervix.

Yup, thom p, you have presented quite an unimpressive argument; like usual.

P.S. thom p, yes cervarix is not gardasil (I had stated that), but what types of HPV targets do they have in common?

P.P.S. thom p as evidenced in the future trials (you know, a group of subjects at risk--i.e. sexually active exposed to HPV 16 and 18 and others...) there is far more evidence of serotype replacement than not. Or, should we ask you, like you've asked others...can you read? Here let's quote it again.

"contribution of nonvaccine HPV types to overall grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ was sizable"

and

"the overall disease incidence regardless of HPV type continued to increase"

I've minimized the above quotes to help ya, but if you need me to actually spell it out, I can or you can try www.m-w.com

P.P.P.S. yup, thom p has confimed what I have said before--"HPV cervical cancer niche fillers = gardasil next generation"-- in his (thom p) words..."If they are, then further serotypes will have vaccines developed against them". Vaccinatory economics and chasing one's tail at its best.





Edited by - whatif on 09/13/2008 04:40:47
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