Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Page 3 - Mothering Forums

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#61 of 189 Old 07-10-2006, 07:04 PM - Thread Starter
 
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Originally Posted by HeatherHeather
The thing I don't understand is why have a control group that small to begin with.
Bingo!
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#62 of 189 Old 07-10-2006, 07:05 PM
 
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LI - we're posting at the same time.

This would be easier in real time.
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#63 of 189 Old 07-10-2006, 07:08 PM
 
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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?
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#64 of 189 Old 07-10-2006, 07:08 PM - Thread Starter
 
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Quote:
Originally Posted by HeatherHeather
LI - we're posting at the same time.

This would be easier in real time.
ETA: we posted at the same time again!

Here's the safety data for Gardasil for those who want to see it in black and white (middle of page 10): http://www.merck.com/product/usa/pi_...ardasil_pi.pdf
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#65 of 189 Old 07-10-2006, 07:10 PM - Thread Starter
 
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Originally Posted by HeatherHeather
The answer is in one of the study designs. Are the research studies published?
I'm sure it has to be somewhere - I'm going by the published data in the ACIP minutes and the product insert.
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#66 of 189 Old 07-10-2006, 07:15 PM
 
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The answer is on page 2 under Clinical Studies. The labeling includes results from 4 studies. The first study included is a Phase II study which is a safety study. The other 3 are Phase III or efficacy studies. The 320 saline placebos were undoubtedly in the Phase II study. Then someone wised up. Actually the FDA requires different things from Phase II and Phase III studies.
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#67 of 189 Old 07-10-2006, 07:17 PM
 
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Does the public have the right to access the actual research data from each of the studies?
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#68 of 189 Old 07-10-2006, 07:22 PM
 
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Actually, I'm surprised they're evaluated for safety at all!

Ruth, single mommy to Leah, 19, Hannah, 18, and Jack, 12
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#69 of 189 Old 07-10-2006, 07:26 PM - Thread Starter
 
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Originally Posted by Ruthla
Actually, I'm surprised they're evaluated for safety at all!
Exactly. I mean why even bother. You're comparing apples . . . to apples.
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#70 of 189 Old 07-10-2006, 07:43 PM
 
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Have you all read the Declaration of Helsinki and it's amendments? It's a document (not sure who wrote it) written in the 1960s and revised later to be a guide for biological research ethics. It prohibits the use of placebo control groups when there is a "proven" treatment for the disease. This is a primary reason why there are no real placebo controled medical trials. (The US signed the declaration). If there is an approved treatment or vaccine for any disease, then it is considered unethical to deny treatment to human subjects, so the new treatment/vaccine has to be tested against the recognized/approved treatment. The declaration was written to protect third-world citizens from being denied treatment, but it has been extremely detrimental to research IMO.

Before children, I was involved in medical research and have been accused by IRBs (internal review boards) and colleagues of being unethical for proposing/having true placebo control groups.
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#71 of 189 Old 07-10-2006, 07:54 PM - Thread Starter
 
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Quote:
Originally Posted by HeatherHeather
Have you all read the Declaration of Helsinki and it's amendments? It's a document (not sure who wrote it) written in the 1960s and revised later to be a guide for biological research ethics. It prohibits the use of placebo control groups when there is a "proven" treatment for the disease. This is a primary reason why there are no real placebo controled medical trials. (The US signed the declaration). If there is an approved treatment or vaccine for any disease, then it is considered unethical to deny treatment to human subjects, so the new treatment/vaccine has to be tested against the recognized/approved treatment. The declaration was written to protect third-world citizens from being denied treatment, but it has been extremely detrimental to research IMO.

Before children, I was involved in medical research and have been accused by IRBs (internal review boards) and colleagues of being unethical for proposing/having true placebo control groups.
The declaration has been amended a few times:

The Declaration has been revised five times, most recently in October 2000, and includes in its 32 principles the statement that "the benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods."

Although it says that this does not exclude the use of placebo or no treatment, in studies where no proven prophylactic, diagnostic, or therapeutic method exists, this stipulation is very controversial, since some interpret it to mean that a placebo should never be used when effective therapy is available, regardless of the seriousness of the condition being studied.


*****************
There is nothing stopping pharma from conducting safety trials using a true placebo control group. Efficacy trials are one thing . . . safety is a different ball game.
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#72 of 189 Old 07-10-2006, 07:59 PM
 
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This is the wording that causes the stir...

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.
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#73 of 189 Old 07-10-2006, 08:05 PM
 
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Boy, I'm digging into the pit of my hard drive for this info. Last edited in 2004 (I think).

Quote:
The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists. See footnote




Note: The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances:

- Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or

- Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.

All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.
Let me assure you that because of this declaration, IRBs will approve almost no placebo controlled studies and when they are approved, you better be ready to take the heat from colleagues.
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#74 of 189 Old 07-10-2006, 08:06 PM - Thread Starter
 
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Quote:
Originally Posted by HeatherHeather
Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.
Pharma is perfectly capable of conducting a safety trial using a true placebo control group without sacrificing the control group's health.
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#75 of 189 Old 07-10-2006, 08:13 PM
 
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Originally Posted by LongIsland
Pharma is perfectly capable of conducting a safety trial using a true placebo control group without sacrificing the control group's health.
Actually LI, the powers that be in the world medical association don't recognize the need for a true "safety" trial. Take for example AIDS. If there is a proven treatment for AIDs then any new medication must be tested against that proven treatment, not against placebo even for a safety trial. It is considered unethical to give some people with AIDs a placebo even for a safety trial when there is a proven treatment. IMO, this is the problem with the declaration. You are comparing safety of one drug to another drug and not a drug against placebo. As a researcher your hands are tied in this. You'd never get it past an IRB.
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#76 of 189 Old 07-10-2006, 08:15 PM - Thread Starter
 
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Originally Posted by HeatherHeather
As a researcher your hands are tied in this. You'd never get it past an IRB.
If you have time, take a look at the RotaTeq insert . . . these trials appear to use a true placebo, but I can't tell from the REST data or the information contained in the product insert.

http://www.merck.com/product/usa/pi_...rotateq_pi.pdf
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#77 of 189 Old 07-10-2006, 08:22 PM
 
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Originally Posted by LongIsland
If you have time, take a look at the RotaTeq insert . . . these trials appear to use a true placebo, but I can't tell from the REST data or the information contained in the product insert.

http://www.merck.com/product/usa/pi_...rotateq_pi.pdf
Yes, a placebo was allowed b/c there was no pre-existing standard of care for rotavirus. However, other vaccines could not be prohibited from being administered with RotaTeq b/c this would be denying the standard of care (except oral polio which is also active in the gut). Now that RotaTeq was approved, any new rotavirus vaccine will have to be evaluated against RotaTeq and no placebo will be allowed.
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#78 of 189 Old 07-10-2006, 08:24 PM
 
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Originally Posted by Plummeting
So are you suggesting that they pick the worst studies, the ones least likely to show that the products are safe, to include in the package insert? They purposely pick and choose between the multitudes of studies, and choose the only research that wasn't properly conducted using a placebo? The research that makes their product seem more dangerous and less effective? They have better studies to choose from, but they use the worst ones to describe their drugs in the package inserts?
No, the studies quoted above were efficacy studies ftmp, and the safety trial process has several more layers than end up in package inserts. IE, the drugs that kill rats don't make it to the "package insert" stage of the process, nor do most drugs that don't kill rats. The package inserts don't contain the results of animal testing, or Phase I-II human trials ftmp, so to look at the above and say "That's it, this here is 100% of the safety testing ever conducted on this product" is misleading.

This document explains the whole process
http://www.fda.gov/Cber/vaccine/vacappr.htm
Clearly, if you look at package inserts only, you don't see the results from all phases.

There are comparative studies up there as well. FE why switch over to DTaP if it's no safer or than DTP, or less effective? Valuable studies, but not the whole story, so I think the "this is it" presentation is again misleading.

The placebo ethics issue is interesting and satisfies me as to why controls might receive a currently accepted, previously safety-tested intervention. Ie I don't find it necessary to go to the "evil pharma wants to obscure adverse effects" theory. And it would explain why new vaxes (rotateq & gardasil fe) would have saline placebos, and others wouldn't. But that's approaching the no-common-language problem that I brought up in the closed thread that got me into this
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#79 of 189 Old 07-10-2006, 08:27 PM
 
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Quote:
Originally Posted by LongIsland
Pharma is perfectly capable of conducting a safety trial using a true placebo control group without sacrificing the control group's health. If the subjects of control group for the licensure of Hib vaccine have already received the appropriate doses of Hib vaccine, there is no reason why they couldn't use those subjects as a true placebo control group. Where is the harm?.
Don't know, but given that vaccines do have risks, which no one denies, exposing already-protected children to a double-dose would expose them to risks without additional benefits, another ethical problem.
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#80 of 189 Old 07-10-2006, 08:30 PM
 
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Originally Posted by ccohenou
The placebo ethics issue is interesting and satisfies me as to why controls might receive a currently accepted, previously safety-tested intervention. Ie I don't find it necessary to go to the "evil pharma wants to obscure adverse effects" theory. But that's approaching the no-common-language problem that I brought up in the closed thread that got me into this
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.
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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.
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#82 of 189 Old 07-10-2006, 08:38 PM
 
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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.
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#83 of 189 Old 07-10-2006, 09:02 PM
 
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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".
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#84 of 189 Old 07-10-2006, 11:45 PM
 
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Most (if not all) of the original vaccine studies weren't placebo controlled.
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#85 of 189 Old 07-11-2006, 12:05 AM
 
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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?
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#86 of 189 Old 07-11-2006, 12:15 AM
 
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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.”

“I want to sell drugs to everyone. I want to sell drugs to healthy people. I want drugs to sell like chewing gum.” former Merck CEO, Henry Gadsden

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#87 of 189 Old 07-11-2006, 01:25 AM
 
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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

“I want to sell drugs to everyone. I want to sell drugs to healthy people. I want drugs to sell like chewing gum.” former Merck CEO, Henry Gadsden

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#88 of 189 Old 07-11-2006, 02:15 AM - Thread Starter
 
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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?
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#89 of 189 Old 07-11-2006, 03:03 AM - Thread Starter
 
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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.
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#90 of 189 Old 07-11-2006, 07:57 AM - Thread Starter
 
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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?
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