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Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Page 5  

post #81 of 189
Quote:
Originally Posted by HeatherHeather
THIS IS THE PROBLEM. Just b/c there is a proven intervention doesn't mean that that method was ever adequately tested for safety. Most of these "proven" treatments were "proven" decades ago. Since medicine advances occur at light speed there are whole syndromes that are diagnosed now that didn't even have a name when the "proven" methods were initially approved.
Not sure what exact vaccines & syndromes you're referring to, but it seems from my journeys through the medical library databases that even "old" vaccines have had quite a bit of ongoing testing as concerns have arisen...not that these are satisfying to all, of course.
post #82 of 189
Quote:
Originally Posted by ccohenou
Not sure what exact vaccines & syndromes you're referring to, but it seems from my journeys through the medical library databases that even "old" vaccines have had quite a bit of ongoing testing as concerns have arisen...not that these are satisfying to all, of course.
I'm talking hypothetical. And not specifically about vaccines.
post #83 of 189
Quote:
Originally Posted by HeatherHeather
THIS IS THE PROBLEM. Just b/c there is a proven intervention doesn't mean that that method was ever adequately tested for safety. Most of these "proven" treatments were "proven" decades ago. Since medicine advances occur at light speed there are whole syndromes that are diagnosed now that didn't even have a name when the "proven" methods were initially approved.
That's exactly what I was going to say. If the original vaccines were never properly safety tested (and they weren't), then we can't use them as a basis for determining whether the newer vaccines are safe.

(Except that I am talking about vaccines.)

How can we say they were ever properly safety tested? Look at all the vaccines that have been pulled from the market, after passing their "safety tests".
post #84 of 189
Most (if not all) of the original vaccine studies weren't placebo controlled.
post #85 of 189
Right, and the *last* rotavirus vaccine was probably a placebo controlled study, yet it somehow still made it to market. We all know how that turned out, and we now also know that the manufacturer knew there were problems before it was released, and the FDA knew (or at least should have known) there were problems. 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?
post #86 of 189

Nothing in the history of vaccination has changed.

On page 435 of the Senate Hearing S.3419 held on April 20, 21 and May 3, 4, 1972 is a chart, exactly as below:

VACCINES REFERRED TO AS INEFFECTIVE BY THE DBS DIRECTOR AND THEIR MANUFACTURERS.

Product listed in report Brand name of product listed in report Manufacturer

1.Product A ……………..Bacterial vaccine mixed respiratory………………….Hollister-Stier Laboratories.
2.Product B………………Respiratory UBA……………………………………….Eli Lilly & Co.
3.Product C……………...Staphylococcus-streptocuccus UBA……………………….Do
4.Product D…………..….Combined vacine No. 4 with catarrhhalis………………….Do
5.Product E………….…..Mixed vaccine No. 4 with H. Influenzae…………………...Do
6.Product F………….…..Staphylococcus vaccine …………………………………….Do
7.Product G……………..Entoral………………………………………………………….Do
8.Product H……………..typhoid H antigen………………………………………………Do
9.Product I……………….Vacagen tablets………………………………………...Merck, Sharp & Dohme.
10.Product J………………Brucellin antigen……………………………………………….Do
11.Product K………………Staphylo-strepto serobacterin vaccine………………………Do
12.Product L………………Catarrhalis serobacterin vaccine mixed………………………Do
13.Product M……………...Sensitized bacterial vaccine H. influenzae………………….Do
Serobacterin in vaccine mixed.
14.Product N……………….Staphage lysate type I………………………………Delmont Laboratories, Inc.
15.Product O……………….Staphage lysate type III……………………………………….Do
16.Product P………………..Staphage lysate types I and III………………………………Do.
17.Product Q………………..Catarrhalis combined vaccine……………….Merrell-National laboratories
(division, Richardson-Merrell)
18.Product R……………..…Strepto-staphylo vatox………………………..Merrell-National Laboratories
19.Product S………………..Staphylococcus toxoid-vaccine vatox ……………………...Do
20.Product T……………..…Respiratory vatox…………………………..………………….Do
21.Product U……………..…Respiratory B.A.C…………………………………Hoffman Laboratories, Inc.
22.Product V………………..Gram-negative B.A.C……………………….………………..Do
23.Product W…………….....Pooled stock B.A.C. No 1 …………………..………………Do
24.Product X…………………Pooled stock B.A.C. No 2………………….……………….Do
25.Product Y…………………Staphylococcal B.A.C……………………………………….Do
26.Product Z………………….Pooled skin B.A.C…………………..………………………Do
27.Product AA………………..Mixed infection phylacogen …………………….Parke, Davis & Co
28.Product BB………….…….Immunovac oral vaccine……………………………………Do
29.Product CC………….…….Immunovac respiratory vaccine (parenteral)……………..Do.
30.Product DD……………….Streptococcus immunogen arthritis. ………………………Do
31.Product EE………………..N. catarrhalis vaccine (combined)…………………………Do
32.Product FF………………..No catarrhalis vaccine immunogen (combined)………….Do
--------------------------------------------------------------------------------------------------------------------------------------------

Just above a heading WORTHLESS VACCINES on page 346, reads:

“SENATOR PERCY. Doctor, right at the outset of your testimony, you make reference to the General Accounting Office report, that 32 vaccines of no known value, and some possible harm, have continued to be licensed. I have never seen a figure as to what the total dollar value of those vaccines would be. What was the cost of the vaccines which were either of little value or perhaps even harmful, and which were administered to people who felt they were being protected?

Below the heading reads:

DR ISACSON. Well, I think it must be astronomical. I do not think I could give you an actual figure. Since some of these appear from the investigation to have been on the market for 20 years, certainly it must add up.

SENATORY PERCY. But we are talking about a cost investment of hundreds of milions of dollars, maybe…. We are locking the barn now after the horse has gone out.”
post #87 of 189
Quote:
Originally Posted by HeatherHeather
My honest guess about the saline control group is that they started the study intending to do all control group subjects as saline control and then some Merck official or FDA official saw it and said, "Are you crazy?" So after they enrolled the first 320 they stopped. I really don't know though. The answer is in one of the study designs. Are the research studies published?
No. They only publish the ones they want to.

Quote:
Originally Posted by HeatherHeather
Does the public have the right to access the actual research data from each of the studies?
As I understand it, not even FDA has the right to access the actual research data. They are only usually given a summary.

with the MenZB trials I asked under the FOI act, for all study/trial protocols, and study results, correspondence between the manufacturer and government, and a whole raft of stuff. The letter says:

Quote:
ingredients, constituents, non active constitues of vaccine is withheld...clinical trials applications attached, protocols witheld, information to volunteers and parents attached...data on effecacy, safety and full dist of all vaccine reactions withheld
post #88 of 189
Thread Starter 
Quote:
Originally Posted by HeatherHeather
Most (if not all) of the original vaccine studies weren't placebo controlled.

Hmmm, I wonder if there's a safety trial for Hepatitis B administered at birth. I don't believe there are any published studies. I suppose the ole saying, "shoot first, ask questions later" would apply here.

Exactly how did the AAP, FDA and CDC determine it was safe to administer Hep B to newborns beginning just hours after birth?
post #89 of 189
Thread Starter 
Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX and placebo versus PedvaxHIB and RECOMBIVAX HB in healthy infants

OBJECTIVES: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX plus placebo and recipients of PedvaxHIB plus RECOMBIVAX HB following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit.

CONCLUSION: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB and RECOMBIVAX HB.

***********

Of course they found "no statistically significant differences." I would have been able to tell you that without wasting time and money conducting this "study." Is it any wonder why researchers and pharma agree with the unethical use of true placebo groups ... it keeps researchers employed and pharma maintains it's hero status . . .

. . . and most importantly, it keeps prolonged and/or high-pitched crying off the contraindication list.
post #90 of 189
Thread Starter 
Quote:
Originally Posted by ccohenou
I don't find it necessary to go to the "evil pharma wants to obscure adverse effects" theory.
You don't find it necessary? That certainly says a lot.

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?

Did aluminum have some sort of therapeutic benefit over saline in the Gardasil study that we don't know about?
post #91 of 189
Quote:
Originally Posted by LongIsland
Hmmm, I wonder if there's a safety trial for Hepatitis B administered at birth. I don't believe there are any published studies. I suppose the ole saying, "shoot first, ask questions later" would apply here.

Exactly how did the AAP, FDA and CDC determine it was safe to administer Hep B to newborns beginning just hours after birth?
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.
post #92 of 189
I cannot believe drug companies get away with this. I cannot.

It's a crime and it's killing people. And nobody except us 'crazy' anti-vaxers seems to care.

What a wonderful !@#$%^& world we live in.

Cue vomit.

Edited to add: Once again, huge hugs and thank you's to LI and MT for all of their hard work and dedication. You're the sole reason many children here (and elsewhere) remain vax free. Be proud!
post #93 of 189
This bears repeating, posted by MT,

"2) In all vaccine trials children are specially selected. No children are allowed who have chronic illness, intercurrent illness, family histories of immunodeficiency or allergy, who were under a certain weight at birth, experience anoxia or other birth problems... the list is endless."

************************************************** *
and I want to add,

Vaccines are not tested in children who are not deemed "healthy", yet when they are licensed, they are given to all children regardless of health.

Vaccines were NOT tested in children like mine, with heart surgery and one lung.

Yet all vaccines were recommended for him.

ETA: There is a mom on another board who did participate in a vaccine clinical trial, and when her child suffered reactions, she pulled him from the trial. When she requested copies of the trial info pertaining to her child, surprise surprise, there was NO record of her child ever having been involved in this trial! So when you read "no reported adverse events" pertaining to a clinical trial, it apparently means no events that we will tell you about!!
post #94 of 189
Quote:
Originally Posted by marilynmama

I worry more about long term effects, than short term (overall). Sore arms, fevers dont bother me. GBS, autoimmune diseases, etc bother me, that should bother everyone.
I couldn't agree more - its the inconspicuous damage that worries me the most - what's happening on the INSIDE of bodies that we can't necessarily see, and the long-term costs involved.

You can't inject a concoction (vaccine) into one's bloodstream containing what it does, and not have some residule damage. I don't get why someone doesn't shout this from the roof tops for all to hear. Actually, I DO get it. But I am wondering why scientists who understand this don't band together and make a huge freakin' deal about all of this...
post #95 of 189
suschi's post reminded me- I saw a study where they intentionally took several individuals out of the results, because of certain reactions. iow- they had reactions, and therefore did not qualify any longer to be part of the safety study.
hmmm...let me think about how to find that.
post #96 of 189
Quote:
ETA: There is a mom on another board who did participate in a vaccine clinical trial, and when her child suffered reactions, she pulled him from the trial. When she requested copies of the trial info pertaining to her child, surprise surprise, there was NO record of her child ever having been involved in this trial! So when you read "no reported adverse events" pertaining to a clinical trial, it apparently means no events that we will tell you about!!
I wonder, in the case of vaccines that require multiple doses, if the reason for supposedly low adverse events isn't because the parents pull their kids out of the study? I know I'd pull my child out if they had an obvious reaction and I'm sure the pharmaceutical companies only include children who complete the study. So if the reaction happens on shot #2 of a 3 shot series & I pull my child out then they become excluded from the study.

Just a theory. Does anyone know if this is how it works?
post #97 of 189
Quote:
Originally Posted by cjuniverse
Once again, huge hugs and thank you's to LI and MT for all of their hard work and dedication. You're the sole reason many children here (and elsewhere) remain vax free. Be proud!
Sometimes "small" is very unsatisfying.

You know, I don't care whether people vax or not; what I care about is that they maked informed assessments, and learn how to think.

Right now, that task looks so impossibly monumental its depressing. Very depressing.

It is easy to "think" dammit, and it seems to me that its the key skill that is being removed from the world of intelligentsia.

Enough. Red tent is due, and menopausal hormones have a lot to answer for today.
post #98 of 189
MT

I believe the system needs to be changed. How is that going to happen? People who have no medical knowledge tend to trust the people who do have medical training or who do various research into different diseases. They are told that vaccines are safe and effective etc and they do appear to prevent specific diseases BUT they have an impact on the immune system that is a long term thing and becomes part of the health problems that they then create more vaccines or steroids or antihistamines or whatever to deal with those added problems. By the time it becomes apparent that there is a problem they then blame it on something else and you are stuck in a loop chasing your tail.

Society is based on leaders - spiritual, political who lead the masses. We have leaders but they are being influenced by industry needs and profit and not the health and well being of the masses. The sad thing is that the masses trust the leaders who should be there for their good but are not.
post #99 of 189
Quote:
Originally Posted by chlobo
I wonder, in the case of vaccines that require multiple doses, if the reason for supposedly low adverse events isn't because the parents pull their kids out of the study? I know I'd pull my child out if they had an obvious reaction and I'm sure the pharmaceutical companies only include children who complete the study. So if the reaction happens on shot #2 of a 3 shot series & I pull my child out then they become excluded from the study.

Just a theory. Does anyone know if this is how it works?
The child and the AE is included in the analysis of adverse events, but not in the efficacy data.

A bigger issue is this: Is a child who has a non-serious AE more likely to have a serious AE at the next shot in the series. In other words, if my child has an AE at shot 1 of the series and I pull him out, would he have been more likely to have a serious AE at shot 2 or 3 of the series? The researchers have no way of knowing this if you pull the child out of the study. So what happens when the vax is approved. I take dc to the ped. and he is vaxed with shot 1 in the series. He has an AE now termed "normal vax reaction". I tell the ped about the reaction at the next visit and am assurred that this is a normal reaction and nothing to worry about. I am pressured to get the full series, b/c dc won't be protected without it My dc gets the next shot. Will he have a more serious AE, no one really knows b/c they don't have the data until years later when they look at the surveillance data via VAERS which we all know captures all reactions. :
post #100 of 189
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