Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Page 8

[HeatherHeather]

Originally Posted by LongIsland

What does he mean by this quote: Bodies aren't the same as Coca-Cola cans.

It was in reference to body parts being bought and sold and becoming commodities like, coca-cola cans.

[HeatherHeather]

Originally Posted by gnu

I understand what you're saying, but am still confused (aka skeptical of the study design). Or better yet, why not use saline placebo throughout the clinical trials?

I agree with you totally on that one.

Originally Posted by gnu

I understand the issues you brought up of double-blinding the study, the need for identical placebo and vaccine containers. You explain that saline containers differ from the identical alum placebo and vaccine containers. But seriously, could this be the limiting factor - containers, given all the research money? Why not put saline in the vaccine-type containers?

Actually it has to do with making the actual liquid look the same, not the containers. The vaxes are usually reconstitued and you have to make the powder and then the resultant liquid look the same to maintain the blind. Probably no easy matter if you are using only saline, but hey, I think they could have done it if they really wanted to.

Originally Posted by gnu

Actually, could you find the aluminum side-effect studies that show no difference in fever, arthritis, etc compared with saline placebo? This is, as far as I know, one of the key complaints in the anti-vax movement - no published safety studies for adjuvants, particularly alum. I would not assume that "there may be other studies that show that the aluminum placebo doesn't increase the incidence of fever, so they never looked at that in this study," until I had that study in front of me.

I've never looked into this. If I have time later, I'll try and look it up, but I doubt the studies exist.

[Momtezuma Tuatara]

Originally Posted by mommy_e

Then what is the point of implying that they don't have the data?

Becuase I know someone who works for the FDA and he told me that they often don't have the basic data, but just summary sheets that look good but say very little.

And then there is the other factor, that they don't have the actual relevant data, because there are currently no toxicity tests which are relevant for humans... therefore on another level the data isn't there for them to have.

Here's an example of what I mean.

The Gold standard text for vaccines is still a 1994 IOM book called Adverse Events Associated with CHILDHOOD VACCINES Evidence bearing on causality. I'm pretty sure its online somewhere, but I don't know where, and don't need to know where, since I own a copy.

Why do I own a copy?

Because a doctor and myself put in a submission to the IOM about Hepatitis B, and IOM in their wisdom quoted us, but completely changed the data to make it look like Hep B was squeeky clean when the data we presented showed that it was highly dangerous.

The Table you need to look at is Table 1 - 1 in this book. Its called "Summary of the Evidence For or Against a Derminantion of a Causal Relation."

The interesting column is the far right one called "controlled observational studies and controlled clinical trials"

In this colum the most predominant entry is "no data" which most doctors interpret to mean that the vaccine is clean.

"No data" means no such thing, because at the end of the table the IOM specifically defines 'No data" to mean "No data indicates that the committee did not find data of this type directly bearing on a causal relation between the vaccine and the adverse event."

In otherwords, the work wasn't done to find out whether or not it would/could happen.

That is another reason why the FDA doesn't have the data. because anything that could possibly undermine any application is either not done, or is left out.

The whole deal is carefully scuptured with acceptance being the only reason to put data in.

THAT is why so many drugs collapse once they hit the market. Even if they are reincarnated for another condition, and have to collapse again.

The system doesn't work. Simple as that.

Maybe they do I don't know. But, that is exactly the opposite of what you implied when you said you didn't think that the FDA had the right to see the data.

I don't think that the FDA has the "right" to see the data, when the company involved sculptures it in the first place.

But here's another thing.

I also think the FDA has its hand in the till anyway, and that people who eventually move from the FDA to the very drug companies they once regulated, got to go there because they worked in an expeditious way to ensure the waters to licensing were super smooth.

[LongIsland]

Originally Posted by Momtezuma Tuatara

I also think the FDA has its hand in the till anyway, and that people who eventually move from the FDA to the very drug companies they once regulated, got to go there because they worked in an expeditious way to ensure the waters to licensing were super smooth.

In America they call it, "I'll wash your back if you'll wash mine."
And CDC and FDA employees have a lot of dirty backs.

Most of them know they will have a nice, cushy pharma job after their government stint.

[Just_Isabel]

First: LI, thanks for starting the thread!

Originally Posted by Plummeting

Apparently, they'd be happy with a study that followed people who ate nothing but twinkies for 5 days, while the control group ate nothing but brownies for 5 days. The study would conclude, after only 5 days, that no one had died or suffered any serious adverse events, and the minor reactions were equal between groups, therefore, eating nothing but twinkies must be safe. If you explain it like that, it suddenly becomes ludicrous, because *everyone* knows you can't survive on twinkies alone, but they just can't quite see how you could possibly draw a comparison between that and vaccine studies. <sigh>

Plummeting, I love this analogy!

Originally Posted by HeatherHeather

The thing I don't understand is why have a control group that small to begin with.

That's what I thought too. It makes no sense.

Originally Posted by LongIsland

As you know, the Gardasil saline placebo SUBgroup contained only 320 subjects.

What was the purpose of giving the overwhelming majority of control group subjects in the Gardasil study aluminum when it would have been considered ethical to give ALL of them saline?

Or, if they were going to have a saline group - why not make it big enough to be of significance? What's the point of having a group, if in the end you say that it's too small to give accurate information on safety?

Originally Posted by gnu

Do you really mean efficacy here? -- How would aluminum adjuvant alone be "responsible for the effects" of a decrease in cervical cancer? (Here's a hint: have any other alum-containing vaccines, like HepB, flu, etc been associated with decreased risk of cervical cancer? If alum were all it took, this would have made news years ago. Sheesh.)

The placebo needed to have been saline to compare against vaccine *side effects* (both saline and alum-containing placebos would have worked for the efficacy req'ts, since neither has an effect on HPV). Alum is known to carry its own risks, and is not a true placebo. That's the gripe.

ITA.

Originally Posted by HeatherHeather

When they did the blinded studies, both "shots" had to look the same. Saline looks different than the vax, so they did the easiest thing to make the two look alike. It has nothing to do with thinking that the aluminum has a therapeutic effect.

Couldn't they have changed the packages so you couldn't see the difference between the two substances? There has to be another solution other than using alum. as a "placebo" for safety trials.

Originally Posted by insider

To approach the issue from a more philosophical angle: If a company has a product patent, meaning no one else can sell that product, then what is the necessity for keeping any of the product data trade-secreted? Let's face it, if the experimental methods provided data showing the vaccine to be truly safe and wonderfully effective, they'd include it in the sales pitch every time. The only reason for secrecy is that public disclosure would harm sales of the product.

For anyone who thinks that trade secrets are about protecting the product from being copied, stolen, etc., take a quick look at live virus vaccines: the attenuation process is the result of accumulated random mutations - if you follow the exact same protocol precisely you'll never produce the same vaccine strain twice. And from a practical standpoint, if you wanted to steal a live virus vaccine, you wouldn't snatch the instructions, start from scratch and reproduce the experimental protocol - you'd get your hands on a vial of vaccine (very easy to do) and use it as seed stock for your own product. That doesn't happen. Why not? Because even if you make your own vaccine you can't sell it - it's illegal for anyone but the manufacturer to sell that vaccine. So why does the manufacturer keep their data trade-secreted?

IMO it's the wrong question to ask how much data the FDA is permitted to audit or how much they actually do audit. It’s more appropriate to ask: Why does the FDA get to look at the product data but we don't? It's not to protect us, it's to protect the manufacturer.

This makes so much sense (what you wrote, not the system). Why do the manufacturers need to hide information if the product is patented, anyway?

[caned & able]

they need to be able to show that serious AE's between the vaccine group and the control group are statistically insignificant ...

What the heck does that mean?

I would like to see a pro-vax'er defend this.

The frustrating thing is that doctors defend this all of the time and everyone believes them. Truly unbelieveable.

[krissi]

The Gold standard text for vaccines is still a 1994 IOM book called Adverse Events Associated with CHILDHOOD VACCINES Evidence bearing on causality. I'm pretty sure its online somewhere, but I don't know where, and don't need to know where, since I own a copy.

FYI, I was curious and googled...anyone who wants to thumb through this book, here's the link:
http://fermat.nap.edu/openbook.php?record_id=2138

[Annikate]

Originally Posted by krissi

FYI, I was curious and googled...anyone who wants to thumb through this book, here's the link:
http://fermat.nap.edu/openbook.php?record_id=2138

Thank you for posting this.

[HeatherHeather]

Originally Posted by Just_Isabel

Couldn't they have changed the packages so you couldn't see the difference between the two substances? There has to be another solution other than using alum. as a "placebo" for safety trials.

Well there are a ton of ways to get around the issue, the drug company just didn't want to, b/c then you might see that the adjuvant causes many of the issues. Oh, and there might be a significant difference b/w AEs in the vaxed vs. control group. And they couldn't let that happen, could they?

[Just_Isabel]

Probably not.

[LongIsland]

[Laurel723]

Can I second the request to get this thread 'immortalized' as a sticky?

[mamabain]

please make a sticky, please. i missed this back when it started, don't want to lose it again...

thanks LI & MT for your info. ya'll rock!

[midstreammama]

Originally Posted by Plummeting

Apparently, they'd be happy with a study that followed people who ate nothing but twinkies for 5 days, while the control group ate nothing but brownies for 5 days. The study would conclude, after only 5 days, that no one had died or suffered any serious adverse events, and the minor reactions were equal between groups, therefore, eating nothing but twinkies must be safe. If you explain it like that, it suddenly becomes ludicrous, because *everyone* knows you can't survive on twinkies alone, but they just can't quite see how you could possibly draw a comparison between that and vaccine studies. <sigh>

Thank you for putting it like that! Great comparison!

[De-lovely]

Originally Posted by annalily

The Food and Drug Administration (FDA) has forsaken its watchdog role. Instead, FDA officials climb like puppies into the lap of the drug company executives who might some day hire them at enormous salaries."[/SIZE][/COLOR]

WOWZERS! Thats such an amazing quote......speechless I am.

[lurve]

I have nothing to add, I just wanted to thank you all for all of this information. You continiously help open my eyes and I want you to know how appreciative I am of all of your work. And please make this a sticky!!!

[lizzie]

Holy COW... like I needed another nail in the coffin of my Blindly Vaxing Mommy Career. LI, MT, other awesome info-laden mamas... You guys are truly appreciated!!

So...if I read these studies and testing guidlines correctly, it's like this, essentially: (Remember Joe Izuzu? Try to hear him saying this) "Hey all you moms and dads! You don't want that sweet baby to die, do you?? Hell no! So here's what we're gonna do - we've got a NEW FABULOUS VACCINE - and it's going to save that baby's life becaaaaaaaauuuuuusse... WE SAY SO!! And the FDA backed us up 100%, even though we've NEVER tested it on a newborn, let alone a newborn with the health struggles YOURS is having!! BUT- DON'T YOU WORRY!! This AMAZING new vaccine DIDN'T KILL or MAIM ANY more BABIES than the last one did !!"

AAAAAAAAARRRRGGHH!!

Originally Posted by Plummeting

So why did it make it to market? Are we to believe this is the only vaccine with recognized problems that ever made it to market?

Cause even if it kills several (or several hundred/thousand/what have you) children, just that little paragraph from the AP in the USA Today or whatever periodical you read saying 'FDA Approves Such and Such Vax" means HUGE money for the stockholders. What stockholders? The ones in congress. The ones in the FDA. The ones in that very company. Every 60-something with an investment portfolio, like -quite possibly- your kid's grandparents. Anyone with a clue or responsible portfolio manager, cause nothing says CHAAAAAAAA-CHING!! in the investment world like Pharma, and few things say it in Pharma like vaccines. And to these @$$ clowns, what's a couple of babies when you're making millions? Or when you're approving a drug after giving whatever half-a$$ed info the company gave you a quick once over, thereby assuring your cozy position as Pointless High-Paid VP of the Month at Merck/Glaxo/Astra Zeneca.. whoever.

Let's not forget that vaccines have this delightful "side effect" of creating a vicious cycle of sickness and poor immunity to everything that creates (in theory) a life-long pharma customer. Say it with me now... CHA-CHING!!

I'm sure the FDA is understaffed and underfunded, and I'm sure that will never change, because as long they can "slave away" under the guise of "those poor government employees" doing as much as they can under all the pressure... they've got sympathy, they've got plausible deniability when things like Vioxx come knocking, and BONUS- they've got that great post-FDA job when/if they get fired, at whatever pharma company they've been in the shower with.

And if nothing else... the least I can do is bump this thread up to the top, and fifth the sticky motion! Sticky it for the children!!


lizzie

[DevaMajka]

Originally Posted by lizzie

BUT- DON'T YOU WORRY!! This AMAZING new vaccine DIDN'T KILL or MAIM ANY more BABIES than the last one did !!" [/COLOR]

that is the funniest thing I've read. Like, ever.

[lizzie]

[LongIsland]