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Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Page 6

post #101 of 189
Thread Starter 
Quote:
Originally Posted by LongIsland
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?

Did aluminum have some sort of therapeutic benefit over saline in the Gardasil study that we don't know about?


?????????
post #102 of 189
Well, I'm not going to get into the middle of this discussion, but in response to the original posts, I wanted to say that when I was originally researching vax and trying to muddle through the scare tactics and half-truths from both sides, what finally decided me was reading the package inserts for the vaccines. After seeing how short these studies were (that apparently were enough to get approved) and how few people they were actually conducted on and that they had no true control group, that is what convinced me.

Then, watching the way the FDA handled the whole thimerisol / autism issue convinced me they were useless. Study after study would come out and say there was a link and the FDAs response was 'that study is too small, that study didn't have this method, blah blah blah' so therefore it proves nothing - the only logical next step is to commission a study big enough and designed properly to prove conclusively that there isn't (or is) a link. But for some reason they didn't see it necessary to do this.

So, I don't trust them to determine what goes into my child.
post #103 of 189
[QUOTE=HeatherHeather]This is the wording that causes the stir...
Quote:
Quote:
II. Medical Research Combined with Professional Care (Clinical Research)

1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, re-establishing health or alleviating suffering.


2.The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.

3.In any medical study, every patient- including those of a control group, if any- should be assured of the best proven diagnostic and therapeutic method.
Heather I have been thinking of this all night. Vaccines should not fall under this category because they are not treating a sick person. In some of the links MT posted the CDC states that most people being vaccinated will never contract the disease even without a vaccine. So to me the fact that they are not using a true placebo is a cop out. Most of the people that these vaccines are used on are perfectly healthy illness free people.
post #104 of 189
I just want to let you guys know that i gave this thread to my SIL to read. My brother has been coming around to the absurdity of some vaxes but she is a tougher nut to crack. I am not sure how much she actually read but it sparked a really great discussion in front of my whole family where she agreed with quite a few of the anti-vax arguments. Before we were done she even said, "I can see where if you were traveling to a foreign country there would be some shots you might want to get" OK I disagree with her but the point is that she must be thinking that if you are here in the US you won't need them. She is expecting in Sept and I am so glad that LI and MT have started this thread. Even if she only skips one or two of the shot series this time, it is all downhill from there.

THANK YOU THANK YOU THANK YOU
post #105 of 189
bump
post #106 of 189
Quote:
Originally Posted by jennkraig
I just want to let you guys know that i gave this thread to my SIL to read. My brother has been coming around to the absurdity of some vaxes but she is a tougher nut to crack. I am not sure how much she actually read but it sparked a really great discussion in front of my whole family where she agreed with quite a few of the anti-vax arguments. Before we were done she even said, "I can see where if you were traveling to a foreign country there would be some shots you might want to get" OK I disagree with her but the point is that she must be thinking that if you are here in the US you won't need them. She is expecting in Sept and I am so glad that LI and MT have started this thread. Even if she only skips one or two of the shot series this time, it is all downhill from there.

THANK YOU THANK YOU THANK YOU
I'm so glad it's helping someone!
post #107 of 189
Quote:
Originally Posted by Momtezuma Tuatara
I have a letter on file which shows that at no point was Hep B evaluated at birth, to see what effect it would have on either liver enzymes, or immune system parameters.
sigh. I hate information.
My ds was vaxed at birth (3 days old?) for Hep B. And you know what pisses me off even more? I (actually both dp and I) was wary of it, but gave in after hearing about how it was safe and the benefits outweigh the risks, and all that idiocy.
sigh.
post #108 of 189
Thread Starter 
post #109 of 189
Quote:
Originally Posted by Momtezuma Tuatara
ccohenou, instead of wimping off and whining in the provaccine thread come back here, and actually argue some science.

You know perfectly well that what we said was correct. Saline is NOT an inert placebo when compared with nothing at all, and furthermore, it was lumped in with aluminium as a placebo.
"Nothing at all" isn't a placebo. "Nothing at all" would wreck the blinding. What are you proposing?

The numbers for saline and aluminum were reported separately from what I saw.

Aluminum was used because in an *efficacy* study, the kind that go in package inserts, one has to show that it's not just the vehicle/adjuvant that's responsible for the effects.

If you're dissatisfied with the study, right on. But to say that the only possible reason it was done the way it was was because of evil pharmaceutical conspiracies is unsupportable IMO.
post #110 of 189
Quote:
Originally Posted by Momtezuma Tuatara
As I understand it, not even FDA has the right to access the actual research data. They are only usually given a summary.
The rest of this thread aside, this statement is not true. With every submission, the FDA is given all data collected on the drug. They do their own analysis and usually audit the company records as well as the individual investigator sites.
post #111 of 189
Quote:
Originally Posted by ccohenou
Aluminum was used because in an *efficacy* study, the kind that go in package inserts, one has to show that it's not just the vehicle/adjuvant that's responsible for the effects.
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.
post #112 of 189
Thread Starter 
Quote:
Originally Posted by mommy_e
The rest of this thread aside, this statement is not true.

With every submission, the FDA is given all data collected on the drug. They do their own analysis and usually audit the company records as well as the individual investigator sites.
Of course, pharma is going to have no problem giving all their data to the FDA. They know their FDA buddies will conceal unfavorable data from the public in order to protect them.

I'll give you just one example of concealing unfavorable data . . . antidepressents and suicide. A little snipped from a 2004 Washington Post article:



FDA Urged Withholding Data on Antidepressants
washingtonpost.com - September 10, 2004

The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday.

Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies, and in one case the agency reversed a manufacturer's decision to disclose that its drug was associated in studies with increased hostility and suicidal thinking among children.
post #113 of 189
Thread Starter 
. . . and then we have the recent court ruling in one of the Vioxx cases wherein it was determined that Merck withheld data from the FDA. Even the editor of the most prestigious medical journal in the world publicly stated Merck concealed crucial data from the FDA.

There are many articles about pharma withholding data to the FDA on various drugs and products. One of the most recent for products is implantable defibrillators. Guidant is actually under investigation as we speak.

Anyone who thinks that pharma is looking out for anyone but themselves needs to pull their head out of the sand. Likewise for the FDA - what did that recent article on another thread say? The FDA really stands for Fast Drug Approval.

Approve the drugs based on those laughable studies and then add black box warning after black box warning because you can't hide the maiming and killing any longer. The FDA will do anything to keep dangerous drugs on the market.
post #114 of 189


As I've said before, I majored in Psychology and specifically I loved doing the research projects and these studies make me want to
:Puke :Puke :Puke
post #115 of 189
I love how the Fluzone vax is approved for pregnant women but should not be given to children under 6 months.
post #116 of 189
Quote:
Originally Posted by LongIsland
Of course, pharma is going to have no problem giving all their data to the FDA. They know their FDA buddies will conceal unfavorable data from the public in order to protect them.

...

[/I]
Fact remains, that the statement that the FDA doesn't even have the right to the data is incorrect. That is all I was addressing.
post #117 of 189
Thread Starter 
Quote:
Originally Posted by mommy_e
Fact remains, that the statement that the FDA doesn't even have the right to the data is incorrect. That is all I was addressing.
And I was addressing your statement, which was also incorrect: "With every submission, the FDA is given all data collected on the drug."
post #118 of 189
Quote:
Originally Posted by LongIsland
And I was addressing your statement, which was also incorrect: "With every submission, the FDA is given all data collected on the drug."
...and the examples you gave were not submissions, but post-marketing data from what I can tell from your blurbs.
post #119 of 189
Quote:
Originally Posted by mommy_e
Fact remains, that the statement that the FDA doesn't even have the right to the data is incorrect. That is all I was addressing.
Where is the information that trumps MT's assertion that the FDA can't see the info?
post #120 of 189
Thread Starter 
Quote:
Originally Posted by mommy_e
...and the examples you gave were not submissions, but post-marketing data from what I can tell from your blurbs.
From a Forbes article regarding participation in clinical trials:
http://www.forbes.com/forbes/2002/1014/234_print.html

Be aware of the potential for financial conflicts of interest. Most trials today are done by doctors in private practice, and more university researchers now have ties to industry. In one widely publicized case, a young man from Arizona with a rare liver disease died in a sudden reaction to an experimental gene therapy at the University of Pennsylvania. The lead researcher had a financial stake in a startup with rights to the technology. A government investigation later found that the researchers failed to fully report side effects. Ask about your doctor's financial stake in the trial and avoid trials where you can't get a straight answer. Consult a doctor uninvolved in the trial.
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