or Connect
Mothering › Mothering Forums › Archives › Miscellaneous › Vaccinations Archives › Resources › Do you know how vaccines are evaluated for safety? Prepare to be surprised.
New Posts  All Forums:Forum Nav:

Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Page 4

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

This would be easier in real time.
post #63 of 189
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?
post #64 of 189
Thread Starter 
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
post #65 of 189
Thread Starter 
Quote:
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.
post #66 of 189
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.
post #67 of 189
Does the public have the right to access the actual research data from each of the studies?
post #68 of 189
Actually, I'm surprised they're evaluated for safety at all!
post #69 of 189
Thread Starter 
Quote:
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.
post #70 of 189
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.
post #71 of 189
Thread Starter 
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.
post #72 of 189
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.
post #73 of 189
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.
post #74 of 189
Thread Starter 
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.
post #75 of 189
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.
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.
post #76 of 189
Thread Starter 
Quote:
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
post #77 of 189
Quote:
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.
post #78 of 189
Quote:
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
post #79 of 189
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.
post #80 of 189
Quote:
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.
New Posts  All Forums:Forum Nav:
  Return Home
  Back to Forum: Resources
Mothering › Mothering Forums › Archives › Miscellaneous › Vaccinations Archives › Resources › Do you know how vaccines are evaluated for safety? Prepare to be surprised.