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Old 11-14-2012, 01:34 PM
 
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I'm not sure that's true. ….

 

 This website (http://www.patentlens.net/daisy/adjuvants/Background/Adjuvant_types.html) talks about how aluminium salts have been used as adjuvants since the 1930s. 

Or maybe it is.  

 

A quick look showed this, which implied it was a new formulation:

http://www.medicalnewstoday.com/releases/47226.php

 

"The immune response against the virus that causes cervical cancer is stronger and sustained following vaccination with GlaxoSmithKline's (GSK) candidate HPVvaccine formulated with the innovative AS04 adjuvant compared to using the same vaccine formulated with a conventional aluminium salt adjuvant. "

 

It is an interesting area to sort out for those interested in adjuvants, and their role in efficacy and vaccine safety.


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Old 11-14-2012, 03:39 PM
 
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Or maybe it is.  

 

A quick look showed this, which implied it was a new formulation:

http://www.medicalnewstoday.com/releases/47226.php

 

"The immune response against the virus that causes cervical cancer is stronger and sustained following vaccination with GlaxoSmithKline's (GSK) candidate HPVvaccine formulated with the innovative AS04 adjuvant compared to using the same vaccine formulated with a conventional aluminium salt adjuvant. "

 

It is an interesting area to sort out for those interested in adjuvants, and their role in efficacy and vaccine safety.


Ah, very interesting. I haven't come across AS04 yet which is still different from the AAHS used in Gardasil but apparently was also selected for a stronger immune response. Makes me wonder whether the immune system is really making antibodies against HPV or just the adjuvant bound to HPV.

http://www.ncbi.nlm.nih.gov/pubmed/17581283


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Old 11-14-2012, 04:17 PM
 
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Here is information on ASO4, which, contrary to prosciencemum's insistence, has NOT been in use for 70 years.  In fact, it is new:

 

http://www.landesbioscience.com/journals/13/TagliabueHV4-5.pdf

 

It was approved for human use in 2008--along with squalene. (My understanding is that squalene-containing vaccines have still not been officially approved

 

Even in 2008, it appears that the question of vaccine-induced inflammation--specifically, ADJUVANT-induced inflammation--was of concern:

 

"Notably, genes for inflammatory cytokines were activated. Thus we still remain with the fundamental question whether it is possible to activate immunity without causing inflammation."

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Old 11-15-2012, 04:34 AM - Thread Starter
 
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Sorry is AS04 the same thing as AAHS that Mirzam23 was talking about? I agree these aluminium salt names are a bit confusing. 

 

I found a discussion addressing parents concerns about aluminium content of vaccines from the American Acadamy of Pediatrics which may be helpful to some: http://pediatrics.aappublications.org/content/112/6/1394.full

 

(it's actually got sections covering many of the concerning ingredients in vaccines, so you can just scroll down to adjuvants). 

 

 So it looks like about 6 years ago, after 70 years of using the same aluminium salt adjuvants there was some development of new adjuvants which are combinations of aluminium salts and other substances (which allow the aluminium content to be lowered, while the adjuvant efficacy is increased). AS04 seems to be one of these 2 "new" (6+ year old) adjuvants. If you look at the rules on licensing new adjuvants I posted up thread they must have been extensively safety tested to be licensed.

 

 Have there been any studies indicating they might be dangerous? 


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Old 11-15-2012, 07:19 AM
 
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I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

 

http://www.bmj.com/content/340/bmj.c712.long

 

 "The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination."


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Old 11-15-2012, 07:52 AM
 
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I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

 

http://www.bmj.com/content/340/bmj.c712.long

 

 The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination.

 

I'm confused.  Why do you not find it to be reassuring?  It shows no significant difference between the two arms.

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Old 11-15-2012, 08:22 AM
 
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I'm confused.  Why do you not find it to be reassuring?  It shows no significant difference between the two arms.

Significant is the key word.  

 

9.1 % miscarriage rate in the control arm versus 14.7% in the HPV arm for pregnancies that started within 3 months of the shot is pretty significant to me.  


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Old 11-15-2012, 08:35 AM
 
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Squalene was in use in H1n1 vaccines in Europe, namely the reactive Pandemrix (which also is preserved with thimerosal). My sister was forced by her hospital (she's a MD) to get it against her will and was sick for 2 weeks close to hospitalization. She also got a big talk to tell everyone to get it. Anyways, Pandemrix's adjuvant, AS03 is a mixture of squalene, polysorbate 80 (which allows crossing of blood brain barrier, as known in drugs for brain tumors and such) and vitamin E. The vaccine itself has been implicated in causing narcolepsy (see Finland; also most people didn't want it and many EU countries ended up burning millions of doses).

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Old 11-15-2012, 09:06 AM
 
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I'm confused.  Why do you not find it to be reassuring?  It shows no significant difference between the two arms.

Significant is the key word.  

 

9.1 % miscarriage rate in the control arm versus 14.7% in the HPV arm for pregnancies that started within 3 months of the shot is pretty significant to me.  

Both groups got vaccines with aluminum; the control got a Hep A vax.

 

 

 

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 Women received either the HPV 16/18 vaccine formulated with the AS04 adjuvant system or a control hepatitis A vaccine consisting of 720 ELISA units of inactivated viral antigen with Alum, formulated in 0.5 ml doses.

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Old 11-15-2012, 09:19 AM
 
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Both groups got vaccines with aluminum; the control got a Hep A vax.

 

 

 

Yup.

 

It still looks like a HPV vaccine  was worse  than Hep A, when if came to miscarriage rate in the following 3 months.  I think this does give us some valuable information, but I would love to see a control group that was unvaxxed.  


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Old 11-15-2012, 09:26 AM - Thread Starter
 
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We can compare to general miscarriage rates to get some idea. A quick Google on that comes up with this page: 

 

http://miscarriage.about.com/od/pregnancyafterloss/qt/miscarriage-rates.htm

 

Which suggests in the first 20 weeks of pregnancy 10-20% of women miscarry. So it would appears these numbers of 9-14% of the women having a miscarriage in a period of 3 months are sadly nothing unusual.


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Old 11-15-2012, 10:12 AM
 
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Yup.

It still looks like a HPV vaccine  was worse  than Hep A, when if came to miscarriage rate in the following 3 months.  I think this does give us some valuable information, but I would love to see a control group that was unvaxxed.  

No, it doesn't. It showed no significant difference. You're right. Significant is the key word. They are talking about statistical significance. If the difference is not statistically significant, and it wasn't with that P value, it means that there is no difference between the two groups.
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Old 11-15-2012, 10:32 AM
 
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We can compare to general miscarriage rates to get some idea. A quick Google on that comes up with this page: 

 

http://miscarriage.about.com/od/pregnancyafterloss/qt/miscarriage-rates.htm

 

Which suggests in the first 20 weeks of pregnancy 10-20% of women miscarry. So it would appears these numbers of 9-14% of the women having a miscarriage in a period of 3 months are sadly nothing unusual.

But they were still higher than the Hep A vaccine rate, which clocked  in at 9.1%.  This is not a small study - what accounts for the discrepancy between the Hep A stat and the HPV vaccine? (oh, I  know, the HPV vaccine they were given…,)

 

The general miscarriage rate would not cut it - the study was for 15-25 year olds from Costa Rica.  Finding the miscarriage rate among 15-25 year old Costa Ricans would be best, but 15-25 year olds is a good starting point.

 

This article puts the miscarriage rate for women in their 20's at about 10%.

http://www.babycenter.com/0_age-and-fertility-getting-pregnant-in-your-20s_1494692.bc


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Old 11-15-2012, 10:52 AM
 
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But they were still higher than the Hep A vaccine rate, which clocked  in at 9.1%.  This is not a small study - what accounts for the discrepancy between the Hep A stat and the HPV vaccine? (oh, I  know, the HPV vaccine they were given…,)

The general miscarriage rate would not cut it - the study was for 15-25 year olds from Costa Rica.  Finding the miscarriage rate among 15-25 year old Costa Ricans would be best, but 15-25 year olds is a good starting point.

This article puts the miscarriage rate for women in their 20's at about 10%.
http://www.babycenter.com/0_age-and-fertility-getting-pregnant-in-your-20s_1494692.bc

Again, the rate was NOT higher in the hep a arm. There was NO STATISTICALLY SIGNIFICANT DIFFERENCE! You quoted the P value yourself as being .16!
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Old 11-15-2012, 11:49 AM
 
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Again, the rate was NOT higher in the hep a arm. There was NO STATISTICALLY SIGNIFICANT DIFFERENCE! You quoted the P value yourself as being .16!

 

 

The P value related to the first set of data (bolded).  

 

I am more interested the second set of data  (italics), which does not mention P value.  

 

 

 

 

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I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

 

http://www.bmj.com/content/340/bmj.c712.long

 

 "The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination."


There is a battle of two wolves inside us.  One is good and the other is evil.  The wolf that wins is the one you feed.

 

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Old 11-15-2012, 12:02 PM
 
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This is how this very mainstream site interpreted the findings of the study I posted  (bolding mine):

 

http://general-medicine.jwatch.org/cgi/content/full/2010/318/7   (division of New England Journal of Medicine)

 

 

"Comment: These findings are reasonably reassuring that Cervarix vaccination does not materially raise risk for miscarriage. However, the data leave some uncertainty about a slightly elevated risk among women who conceive within 3 months of vaccination. Additional studies are warranted to settle this question."


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Old 11-15-2012, 12:05 PM
 
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The P value related to the first set of data (bolded).  

I am more interested the second set of data  (italics), which does not mention P value.  

Read the whole paper. The P value is in there. It's .033. Still not significant, using the standard of .025.
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Old 11-15-2012, 12:25 PM
 
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Oh, but you are jumping to incorrect conclusions.

We don't know that there's no difference in major events which require hospitalization following the vaccine.

Most "studies" set up by pharmaceutical companies are deliberately set up to hide evidence of problems. See the recent whistleblower lawsuit against Merck by Merck's own virologists for a good example. That kind of thing is KNOWN in the industry to be standard procedure.

Severe reactions to vaccines do not always require hospitalizations, and severe reactions might happen within a short time frame--or several weeks later.

This study did not compare vaccinated vs unvaccinated for hospitalizations. It compared vaccinated vs. vaccinated. Basically, it compared the likelihood of hospitalization immediately after vaccination with the likelihood of hospitalization somewhat later after vaccination.

They were very careful not to let us know that the hospitalization rate is significantly higher in those who have received the vaccine.

Yeah, that's really reassuring.

 

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Yet another piece of junk science designed to mislead and hide the dangers of vaccination. Thankfully more people are waking up to this hoax and are just saying NO.

 


Yep. My daughter WILL NEVER get this vaccine, or any other, as long as dh and I are in charge of her health.


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Old 11-15-2012, 03:07 PM
 
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Sorry is AS04 the same thing as AAHS that Mirzam23 was talking about? I agree these aluminium salt names are a bit confusing. 

 

I found a discussion addressing parents concerns about aluminium content of vaccines from the American Acadamy of Pediatrics which may be helpful to some: http://pediatrics.aappublications.org/content/112/6/1394.full

 

(it's actually got sections covering many of the concerning ingredients in vaccines, so you can just scroll down to adjuvants). 

 

 So it looks like about 6 years ago, after 70 years of using the same aluminium salt adjuvants there was some development of new adjuvants which are combinations of aluminium salts and other substances (which allow the aluminium content to be lowered, while the adjuvant efficacy is increased). AS04 seems to be one of these 2 "new" (6+ year old) adjuvants. If you look at the rules on licensing new adjuvants I posted up thread they must have been extensively safety tested to be licensed.

 

 Have there been any studies indicating they might be dangerous? 


No AS04 and AAHS are not the same. Both are new adjuvants and other than in Cervarix (AS04) and Gardasil (AAHS), I have not seen it listed as being used in other vaccines. So an adjuvant with 'just' 6 years under its belt and almost exclusively used in teenage girls, is not what I would consider safe and sound. About the extensive safety tests that you mention, I would like to learn more about it and would like to know when and how these were undertaken. So have there been studies for AAHS and AS04 that are available?

Just because one aluminium salt may be injected without doing immediate harm does not mean all other salts containing aluminium are therefore safe to use. Just take barium as an example. All barium salts are toxic except for barium sulfate which is used as an X-ray contrast agent.


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Old 11-15-2012, 03:37 PM
 
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Again, the rate was NOT higher in the hep a arm. There was NO STATISTICALLY SIGNIFICANT DIFFERENCE! You quoted the P value yourself as being .16!

 

 

The P value related to the first set of data (bolded).  

 

I am more interested the second set of data  (italics), which does not mention P value.  

 

 

 

 

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I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

 

http://www.bmj.com/content/340/bmj.c712.long

 

 "The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination."

 

In October 2007 the European Medicines Agency listed the estimated rate of miscarriage as 11.0 % in the HPV arm and as only 5.7 % in the control arm. Unfortunately the URL is no longer available. So was the PATRICIA study retaken or did they adjust the findings?


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Old 11-15-2012, 04:35 PM
 
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The thing about gardasil not being tested with a true placebo didn't sit right with me.  I think having everything but the pathogen as a placebo is legit, but at some point it was surely tested against saline.  Turns out, it was.

 

From the gardasil insert:

 

 

 

Quote:
 
In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline 
placebo-controlled, and 1 uncontrolled), 18,083 individuals were administered GARDASIL or AAHS 
control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and 
safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each 
injection of GARDASIL or AAHS control or saline placebo in these individuals. 

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf

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Old 11-15-2012, 04:39 PM
 
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I also thought this was interesting, the list of studies merck was required to do  in order to get their initial licensure for gardasil.  Yes, these studies were funded by merck.  Who should bear the brunt of funding them other than merck?  I think knowing where funding came from is an important consideration, but doesn't not automatically ruin a study.  Depending on how things were set up it's very possible for research to be independent, even if it's industry funded.

 

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111283.htm

 

 

I was going to quote, but the list is far too long for copy right requirements.
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Old 11-15-2012, 11:27 PM
 
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Depending on how things were set up it's very possible for research to be independent, even if it's industry funded.

 

Possibly, but seeing how unethical and money-hungry this industry is it would take a lot for me to trust it.


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Old 11-16-2012, 06:26 AM
 
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That's your opinion and you're entitled to it.
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Old 11-16-2012, 06:37 AM
 
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That's your opinion and you're entitled to it.

And yet you replied that you're not sure if you would vaccinate your mythical daughter. Do you trust the vaccination industry, or not?
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Old 11-16-2012, 06:55 AM
 
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Old 11-16-2012, 06:55 AM
 
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Lets not make this about me, please.
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Old 11-16-2012, 07:31 AM
 
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Lets not make this about me, please.
Agreed. This thread is not about Rrrrachel's personal decision regarding her mythical teenage daughter. Topical, not personal, everybody. Do I need to add that to my sig??

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Old 11-16-2012, 07:32 AM
 
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 Do you trust the vaccination industry, or not?

Not Rachel, but this is a very interesting question!

 

I think most people fall on a spectrum. One end - complete distrust for the vaccine industry.  Other end - complete acceptance of the vaccine industry.  I don't think either extreme is necessarily balanced (for lack of a better word) as it clouds objectivity, logic and ability to keep an open mind.

 

I actually like it when someone who identifies as pro-vax or non-vax concedes that they are not 100% devoted to either extreme - it shows an open-mindedness that leads to better discussion.

 

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There is a battle of two wolves inside us.  One is good and the other is evil.  The wolf that wins is the one you feed.

 

Book and herb loving mama to 1 preteen and 2 teens (when did that happen?).  We travel, go to school, homeschool, live rurally, eat our veggies, spend too much time...

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Old 11-16-2012, 08:46 AM
 
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Originally Posted by Rrrrrachel View Post

I also thought this was interesting, the list of studies merck was required to do  in order to get their initial licensure for gardasil.  Yes, these studies were funded by merck.  Who should bear the brunt of funding them other than merck?  

 

 

 

 

The government, for one.

 

If the government is involved in either paying for or mandating the vaccine, I think it has a responsibility to ensure safety through independent study.


There is a battle of two wolves inside us.  One is good and the other is evil.  The wolf that wins is the one you feed.

 

Book and herb loving mama to 1 preteen and 2 teens (when did that happen?).  We travel, go to school, homeschool, live rurally, eat our veggies, spend too much time...

kathymuggle is online now  
 

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