Gardasil vaccine

[robinson]

http://www.urbandictionary.com

 

[fls]

So what was the super-duper amazing discovery you made, Robinson? If you don't have time to fill in the blanks, tell us and we'll do it for you. Let us shoulder some of your burdens.

Linda

 

[robinson]

I'm chagrined to find that it wasn't anything new, at least to the groups questioning and criticizing vaccines and vaccine policy. Kind of took the wind out of my sails that.

Still researching the matter, as well as related stuff. It's very complicated. But no mystery to those in the midst of the battle.

If I had spent any time on sites critical of vaccines I would have known about it a year ago. What I get for spending all my time here.

 

[robinson]

Oh wait, I still didn't tell you. OK, here is the short version. Maybe somebody here will actually look into it. Hope springs eternal.

To recap, Gardasil is effective at preventing HPV, at least the strains used in the vaccine. How this translates to cancer prevention is an unknown, but it should help. It also can prevent genital warts, a good thing.

What I found unbelievable, and after checking and rechecking, I am 100% sure about this, is that the clinical trials they used to get FDA approval, and to claim the vaccine is safe, used Aluminum salts as a"placebo".

I'm not kidding, it is right there in the pdf we discussed earlier.

More accurately, they used amorphous aluminum hydroxyphosphate sulfate dissolved in saline. Some trials used a huge dose of it, others they refuse to reveal the amount used.

There are several other issues as well, but that is the glaring big error that I didn't even see at first.

I first noticed it when the claims about side effects from the vaccine VS the placebo made no sense at all. One study, the "placebo" had more side effects than the vaccine, which made no sense at all.

I leave it to Eos, Skeptigirl, or some other bright light to explain just how wrong it is to use something that has known side effects as a placebo.

It is also wrong to refer to 800mcg of amorphous aluminum hydroxyphosphate sulfate dissolved in saline, as a Placebo.

Placebo has a specific meaning, replacing a harmless substance with something that produces as many side effects as the drug you are testing, (or worse, more side effects), is just bad science. It is terrible medicine.

It is crap.

I'm sure somebody will try and say something like this, "Well, we wanted to know what the active vaccine ingrediants did compared to just the adjuvant", or "This is standard procedure for vaccine testing", or some other excuse for what is obviously BAD science.

So when they compare the side effects with "placebo", they really mean compared to to a big shot of aluminum salts injected into muscle tissue. Not the same thing as a placebo at all.

In fact, a huge dose of salt into muscle tissue doesn't sound like a placebo either, but that is another issue.

I was in no hurry to bring the matter up here, knowing full well no amount of evidence will sway those who have made up their minds already.

But for you skeptics, don't you find that odd? That in multiple trials they would claim they used a placebo, when they didn't? Imagine if some woo woo trial used such shoddy science. You would hear the skeptics creaming for miles about it.

Yet here we have a huge Pharma making huge profits off a new vaccine, trying to get it Government sanctioned, trying to make it mandatory, and they used deceptive means to downplay the side effects.

On the positive side, it illustrates the deep problem intelligent people have with the vaccine industry.

There is a bunch more, but I don't really care that much right now. You go research it for a few weeks. Then get back to us.

Everybody else, just start jabbering away, throw in some personal attacks, use the term anti-vaxxer, explain how everybody but you is wrong, you know, the the usual nonsense. It makes you look soooo inteligent.

 

[Eos of the Eons]

Basically you've just said you have no clue how placebo controlled trials work. No surprise here.

You've just embarrased yourself supremely, that's all, that's it.

If I were you, I'd walk away and not come back until I took some biology courses, some organic chemistry courses, and some general laboratory courses.

PS: look up "saline" solutions while you're at it, and get a basic math course too.


And look up what "profit" means. Since "big pharma" makes pretty much a nil buck off of vaccines, you clearly have no idea what "profit" means.

 

[robinson]

Mental blindness, it is a curious phenomenon.

 

[Eos of the Eons]

You really shouldn't insult yourself on top of embarrassing yourself.

 

[robinson]

It is fun to spar with paranoid stretching/reaching and straw piles every once in a while, bwa ha.

Yes, yes it is. Not very productive, but fun somehow.

Yes, yes, I know. It is then worth it to note that the control group that didn't get the vaccine had more suicides and fatal self-inflicted overdoses though.

Yep. Like I said, why would a control group, one that got a harmless placebo, have more side effects than the vaccine? When you realize they didn't get a harmless placebo, it all starts to make more sense.

I guess the body instinctively knows you're gonna die of cancer anyway, so it subconsciously programs your brain to think you might as well off yourself with various toxic substances to spare the body of that particular doom.

No, but that kind of dumb thinking is a good example of how some people try to make the discussion emotional, rather than scientific.

You know what is hugely ironic?

In this case, I actually do. Because you, and everybody else, missed the obvious flaw, you are arguing from ignorance. Which is pretty funny. Ironic even.

Antivaccinators that are soooo paranoid of any toxin under the sun, even those we eat in food every day because it occurred naturally in soil before any human ever walked the earth, that smoke and take in the worst toxic substances that aren't found naturally in food everyday and destroy their lungs with a horrible addiction.

That has nothing to do with the science, and the problems with vaccines, and vaccine trials. Or side effects. It is a straw dog, it serves to sidetrack the conversation, avoid the issue. Fun, but not really helpful.

Yet it's worse to protect children from preventable damage by diseases? Yep. I know several personally that think that way. Hilarious, sad, wacky.

Here we have one of the core issues. Rather than look at the concerns over possible side effects, dealing with the real issues, vaxxer fanatics go with emotional arguments, strawmen, red herrings and of course the personal attacks.

Anything but discuss the real issues.

It's ironic, because they claim their "enemies" engage in such behaviors.

Like we see here, rather than do any research, look at the studies, investigate the science, we see personal attacks, no evidence at all, and emotional responses.

On the "antivaccine" sites I find vast amounts of science, studies, real research and thoughtful discussions about the possible reasons for bad reactions, the health risks, intelligent concerned people looking for answers. (Not all of them, some are crazy). But there are Doctors and researchers and all kinds of people looking at the reality and the problems.

Insisting their is no problem, that is just insane.

The Gardasil studies alone show one of the main problems. And it isn't an unknown. I found researchers who are looking for ways to make vaccines work without Alum, based on known problems with it.

Much more productive than hiding ones head in the sand, waving the hands and claiming there can't be a problem.

 

[Eos of the Eons]

Omigosh, You're hilarious. My gut hurts from laughing.

One question... are you actually suggesting plane crashes and suicides are a result of the placebo...are you actually suggesting these were side effects?

*tries to make a serious face*

(takes out normal population rates for the "side effects" and compares them to the control group rates)

Hmm. I don't see anything out of place here.

 

[Eos of the Eons]

 

[fls]

Oh wait, I still didn't tell you. OK, here is the short version. Maybe somebody here will actually look into it. Hope springs eternal.

To recap, Gardasil is effective at preventing HPV, at least the strains used in the vaccine. How this translates to cancer prevention is an unknown, but it should help. It also can prevent genital warts, a good thing.

What I found unbelievable, and after checking and rechecking, I am 100% sure about this, is that the clinical trials they used to get FDA approval, and to claim the vaccine is safe, used Aluminum salts as a"placebo".

I'm not kidding, it is right there in the pdf we discussed earlier.

More accurately, they used amorphous aluminum hydroxyphosphate sulfate dissolved in saline. Some trials used a huge dose of it, others they refuse to reveal the amount used.

There are several other issues as well, but that is the glaring big error that I didn't even see at first.

I first noticed it when the claims about side effects from the vaccine VS the placebo made no sense at all. One study, the "placebo" had more side effects than the vaccine, which made no sense at all.

I leave it to Eos, Skeptigirl, or some other bright light to explain just how wrong it is to use something that has known side effects as a placebo.

It is also wrong to refer to 800mcg of amorphous aluminum hydroxyphosphate sulfate dissolved in saline, as a Placebo.

Placebo has a specific meaning, replacing a harmless substance with something that produces as many side effects as the drug you are testing, (or worse, more side effects), is just bad science. It is terrible medicine.

It is crap.

I'm sure somebody will try and say something like this, "Well, we wanted to know what the active vaccine ingrediants did compared to just the adjuvant", or "This is standard procedure for vaccine testing", or some other excuse for what is obviously BAD science.

So when they compare the side effects with "placebo", they really mean compared to to a big shot of aluminum salts injected into muscle tissue. Not the same thing as a placebo at all.

In fact, a huge dose of salt into muscle tissue doesn't sound like a placebo either, but that is another issue.

I was in no hurry to bring the matter up here, knowing full well no amount of evidence will sway those who have made up their minds already.

But for you skeptics, don't you find that odd? That in multiple trials they would claim they used a placebo, when they didn't? Imagine if some woo woo trial used such shoddy science. You would hear the skeptics creaming for miles about it.

Yet here we have a huge Pharma making huge profits off a new vaccine, trying to get it Government sanctioned, trying to make it mandatory, and they used deceptive means to downplay the side effects.

On the positive side, it illustrates the deep problem intelligent people have with the vaccine industry.

There is a bunch more, but I don't really care that much right now. You go research it for a few weeks. Then get back to us.

Everybody else, just start jabbering away, throw in some personal attacks, use the term anti-vaxxer, explain how everybody but you is wrong, you know, the the usual nonsense. It makes you look soooo inteligent.

Thank you Robinson. You did not disappoint.

The control group needs to be treated in exactly the same way as the treatment group except for the characteristic of interest, if you wish to be able to draw conclusions about the effect of the characteristic of interest. This means that a fake treatment that is identical to the real treatment in all other ways often needs to be created. This is known as a placebo. The placebo vaccines contained the same amount of aluminum as the real vaccines - either 225 mcg or 450 mcg (I have no idea where you got the idea that the amount wasn't listed or where the 800 number is from). Or they contained saline, which is basically the same stuff that is coursing throughout your body at this very moment. If you give something different from the vaccine, then you don't know for sure which effects are due to which vaccine components.

Linda

 

[robinson]

Omigosh, You're hilarious. My gut hurts from laughing.

Thanks. I try.

 

[robinson]

The control group needs to be treated in exactly the same way as the treatment group except for the characteristic of interest, if you wish to be able to draw conclusions about the effect of the characteristic of interest.

That goes without saying. In this case, the vaccine is the substance being tested. Alum is part of the vaccine.

This means that a fake treatment that is identical to the real treatment in all other ways often needs to be created. This is known as a placebo.

No, that is not the definition of Placebo. Which is why I pointed out that the definition of placebo has been changed. Which is just wrong, on so many levels.

Placebo
Etymology: Latin, I shall please
1 a: a usually pharmacologically inert preparation prescribed more for the mental relief of the patient than for its actual effect on a disorder b: an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (as a drug)

^Webster
I'm not even going to argue over the definition of Placebo. The entire "Placebo effect", as well as the "Nocebo effect", is based on a substance having no effect at all. If it can cause a real effect, it can't be called a Placebo. Well, one can try and call something else a Placebo, but it would be a lie.

The placebo vaccines contained the same amount of aluminum as the real vaccines - either 225 mcg or 450 mcg (I have no idea where you got the idea that the amount wasn't listed or where the 800 number is from).

I didn't check my notes, the number may have been cumulative, which would explain the 900mcg figure, as well as the 1350mcg figure. Total dose.

The "placebo vaccines", that is an interesting phrase. I knew somebody would try and rationalize the entire issue, so you did not disappoint.

Or they contained saline, which is basically the same stuff that is coursing throughout your body at this very moment.

No, saline is not what is coursing through our bodies. Saline is used when giving fluids to prevent changing the electrolyte balance, which is very much like salt water. But blood is not saline solution.

That being said, injecting what is coursing through our body, (whole blood), into muscle tissue, is going to cause a whole lot more distress than just saline solution. But that is another topic.

If you give something different from the vaccine, then you don't know for sure which effects are due to which vaccine components.

That is just nonsense. But this entire conversation has clarified something. In regards to double blind placebo controlled trials.

This could be an entire topic.

But since I'm not starting one right now, I will continue.

 

[robinson]

In regards to Gardasil, it is obvious that the purpose of the vaccine trial was to see if it prevented infection with the HPVs included in the vaccine.

That is a no brainer. You compare those vaccinated with those not vaccinated, and you can tell if it works or not. You don't need a placebo or blinding to test that. Like with many medical treatments, you don't need a placebo or blinding to know if it is effective.



So why even use a placebo in the trial? Why a double blind trial? Because we need to know something else, which is just as important.

Is the vaccine safe. What are the side effects.

Which brings us back to how this started. How could an inert, harmless substance cause MORE side effects than the vaccine? It made no sense. How could a harmless substance, used to compare with the real treatement, have worse side effects? How could all those girls imagine all those horrible, painful side effects from a simple saline injection?

How could an inert, harmless substance result in MORE problems that a drug? That is some powerful placebo effect.

Of course once I found it wasn't a placebo at all, it all clicked.

I looked at other studies, and found a similar situation. Then I thought back and realized I have read studies where the same sort of results show up. The placebo is almost as bad as a potent drug at causing side effects, Headaches, stomach problems, dizziness, vomiting, all kinds of stuff. I always wondered what mechanism could cause such a powerful effect, from a simple little pill of milk sugar.

Hmm, a mystery.

But, if as Linda has stated, a Placebo isn't a harmless sugar pill, but can be a potent dose of some substance that has real effects, well, that whole placebo controlled trial thing takes on a whole new meaning.

How interesting.

 

[Capsid]

The aluminium salt is an adjuvant that stimulates the immune system and thereby optimises the response to the immunogens in the vaccine. Since it has an effect it is included in the placebo group as a control for the aluminium's activity against any in the vaccine group. This means the only difference between the two groups is the HPV component. So by your definition, given aluminium salts are not an inert substance, it's not strictly a placebo, however, in scientific usage the group receiving the aluminium salts is referred to as a placebo group and that's generally accepted.

Linda has explained what a controlled trial is designed to do, and this is the proper way to do it, why is it a mystery?

if you remove blood cells and proteins from blood you have saline and that is why it is used as a diluent.

 

[fls]

That goes without saying. In this case, the vaccine is the substance being tested. Alum is part of the vaccine.

What is being tested is the HPV antigens. I would have thought you would be pleased - including the same aluminum salts in the control treatment means that one doesn't have to assume that they are without effect. I thought that was what you wanted?

No, that is not the definition of Placebo. Which is why I pointed out that the definition of placebo has been changed. Which is just wrong, on so many levels.
^Webster

Ah, a fellow naming nazi. A discussion that predates the birth of both you and me - can language be allowed to evolve? Should a dictionary definition reflect the way the word is used, or serve as a standard? Considering that many 'placebo' treatments contain components that are active (from vitamins to sham acupuncture) (and for that matter, how can something that contains both taste and calories be 'inert'?) and that 'placebo' groups rarely (if ever) are treated in a neutral manner (from the attention of participating in a study to regular laboratory monitoring to the addition of other active treatments), how can we claim that 'placebo' is the word that best describes the treatment received by the control group, even if everyone understands what is meant? And what makes it even worse is that the original root is 'placere' or 'to please' - "a medicine given for the purpose of pleasing or humoring the patient, rather than for its therapeutic effect."* How is jabbing a needle into someone meant to please? We should have sent the control group off to the spa if we wanted to give them a proper placebo!

That you have only just discovered this issue disturbs me - I have apparently done a poor job of promoting a complaint near and dear to me. You have, however, provided me with ammunition against the claim that referring to the treatment given to the control group as a 'placebo' accurately conveys the necessary information. Your abject confusion gives lie to this.

I'm not even going to argue over the definition of Placebo. The entire "Placebo effect", as well as the "Nocebo effect", is based on a substance having no effect at all. If it can cause a real effect, it can't be called a Placebo. Well, one can try and call something else a Placebo, but it would be a lie.

Hallelujah!

The "placebo vaccines", that is an interesting phrase. I knew somebody would try and rationalize the entire issue, so you did not disappoint.

As I told you earlier, once you know something, it's hard to unknow it.

No, saline is not what is coursing through our bodies. Saline is used when giving fluids to prevent changing the electrolyte balance, which is very much like salt water. But blood is not saline solution.

Yeah, in the same way that the air we breathe is not oxygen and nitrogen.

Linda

*Gould's Medical Dictionary, 3rd ed., 1931

 

[Ivor the Engineer]

Google has a book on Aluminium toxicity with a chapter on aluminium adjuvants:

http://books.google.co.uk/books?id=...nts&sig=MRPn6F-QrG94b_RkkFtO-ph8okI#PPA217,M1

ETA: Exposure to aluminium is about 10mg per day, mostly from food. Absorption through the gut is very low (<1%) and the primary route of elimination is through the kidneys.

 

[fls]

In regards to Gardasil, it is obvious that the purpose of the vaccine trial was to see if it prevented infection with the HPVs included in the vaccine.

That is a no brainer. You compare those vaccinated with those not vaccinated, and you can tell if it works or not. You don't need a placebo or blinding to test that. Like with many medical treatments, you don't need a placebo or blinding to know if it is effective.



So why even use a placebo in the trial? Why a double blind trial? Because we need to know something else, which is just as important.

Is the vaccine safe. What are the side effects.

Which brings us back to how this started. How could an inert, harmless substance cause MORE side effects than the vaccine? It made no sense. How could a harmless substance, used to compare with the real treatement, have worse side effects? How could all those girls imagine all those horrible, painful side effects from a simple saline injection?

How could an inert, harmless substance result in MORE problems that a drug? That is some powerful placebo effect.

Of course once I found it wasn't a placebo at all, it all clicked.

I looked at other studies, and found a similar situation. Then I thought back and realized I have read studies where the same sort of results show up. The placebo is almost as bad as a potent drug at causing side effects, Headaches, stomach problems, dizziness, vomiting, all kinds of stuff. I always wondered what mechanism could cause such a powerful effect, from a simple little pill of milk sugar.

Hmm, a mystery.

But, if as Linda has stated, a Placebo isn't a harmless sugar pill, but can be a potent dose of some substance that has real effects, well, that whole placebo controlled trial thing takes on a whole new meaning.

How interesting.

I'm afraid that doesn't help you much, since the control group may be getting as much effect as the treatment group, but it doesn't get more. I can help you figure it out, but I think it's my turn to return the favour. Let's see what you can work out on your own, first.

Linda

 

[Eos of the Eons]

Well, typical antivaxxer. Totally uneducated on the topic, but still figuring they know more than the people who spend their lives doing their jobs. Some are worse at it than others, but still cause the same kafuffles and long pointless arguments from ignorance.

You have patience of steel Linda, kudos to you, and keep up the great work.

Robinson still doesn't get that everything under the sun is written into the study, whether it was caused by what is being studied or something completely unrelated. When the data is gathered it is compared to other data to see if anything actually sticks out. He also doesn't get the control group and why they get what they do. So, now he's convinced the placebo can be "just as bad or worse" than what is being studied. And he'll spread that around to his little lay friends and convey misinformation about science that all know-it-alls have done for centuries. Whee.

And science is the bad guy? Argh.

 

[Skeptic Ginger]

[see Eos' post for funny cartoon]