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[ctv]Canadian-made HIV vaccine approved for human testing - Page 9

post #81 of 94
Quote:
Originally Posted by matty0610 View Post

Well now I have a question. What if no one placebo or not gets HIV within the 3 years? How do you tell if the vaccine actually worked? Would there be anti-bodies or something in the body that fights HIV?
What if no one got it and there weren't any anti-bodies? Then how do you the vaccine works short of injecting them with HIV?

just a guess, they will likely test this in high risk groups... (ie msm who don't use condoms, intravenous drug users etc...) and then compare the results of those who received placebo against those who received the real deal ...
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post #82 of 94
They normally switch midway the people taking the treatment with those taking the placebo so that it's fair.
post #83 of 94
Quote:
Originally Posted by Usario View Post

inb4 the vaccine kills everyone who gets it

This along with the fact that double-blindness is necessary in ANY legitimate treatment study is the reason there's a control. Don't discount the power of suggestion, either. Even in trials like this, where you wouldn't think the placebo effect could actually occur, it has been demonstrated that it can make a statistically relevant difference.

http://en.wikipedia.org/wiki/Cutter_Laboratories

This is completely beside the fact that the assumption that the placebo group in this study is completely untreated is false. Controlled studies of heart failure medications require the use of an already established drug as a background control in both the treatment and placebo groups. The same stands for vaccine trials.

http://www.nejm.org/doi/full/10.1056/NEJM199501053320114

Edit:
Quote:
Originally Posted by HopeUTKN View Post

They normally switch midway the people taking the treatment with those taking the placebo so that it's fair.

Yup. Crossover trials are very common.
Edited by aroc91 - 2/8/12 at 6:43pm
    
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post #84 of 94
I;m not sure why some people are so hung up on the concept of a placebo? Is it because it is a funny sounding word? I don't expect everyone to understand the exact method by which scientific research must be conducted, but arguing against a control in an experiment is silly.

The placebo is in place to rule out secondary factors that are endemic to a population. This could be water, food, air, etc. With a test of this level of importance, it is imperative to identify the presence of any external factors that could shadow the effectiveness of the vaccine. People are denied the drug for scientific credibility and accuracy; not malice and profiteering.
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post #85 of 94
Good thing it's made in Canada, amirite?
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post #86 of 94
Thread Starter 
Quote:
Originally Posted by Solarin View Post

I;m not sure why some people are so hung up on the concept of a placebo? Is it because it is a funny sounding word? I don't expect everyone to understand the exact method by which scientific research must be conducted, but arguing against a control in an experiment is silly.
The placebo is in place to rule out secondary factors that are endemic to a population. This could be water, food, air, etc. With a test of this level of importance, it is imperative to identify the presence of any external factors that could shadow the effectiveness of the vaccine. People are denied the drug for scientific credibility and accuracy; not malice and profiteering.

Yea but I don't think you can just will power away HIV. Things like muscle pain and what i can understand, but a virus?
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post #87 of 94
Quote:
Originally Posted by matty0610 View Post

Yea but I don't think you can just will power away HIV. Things like muscle pain and what i can understand, but a virus?

I'm not sure what you mean. You are correct that no amount of wishing will cure a systemic and persistent viral infection like HIV. "Mind over matter" is probably close the bottom of the list of factors under consideration when a control group is used in a clinical trial.
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post #88 of 94
Quote:
Originally Posted by matty0610 View Post

Yea but I don't think you can just will power away HIV. Things like muscle pain and what i can understand, but a virus?

Nobody said it, alone, would get rid of the virus. The placebo effect has been demonstrated to increase immune system response in general, release endorphins, and raise body temperature, which actually does help fight bacteria and viruses, as they can be sensitive to higher temperatures; that's the basis for the fever response.
    
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post #89 of 94
Quote:
Originally Posted by KittensMewMew View Post

I understand how a drug trial works, I just don't understand the point of a placebo group in this study.

Then you don't understand how a drug trial works. You can't say, "I understand how a drug trial works" and then right after that say, "Why do they need a placebo group in this drug trial?"

Another reason to have a placebo control group is to establish statistical significance of the results. Without that, you can't scientifically say that the drug worked or it didn't work.

Nobody is being tricked into getting placebo. These trials are done with consent and understanding.

Those who are appalled by this notion: why aren't you vehemently against the sale of cigarettes and alcohol (and unhealthy food for that matter)? There are people who ruin their lives by voluntarily consuming them. Those things don't even have a huge potential to benefit humanity like an HIV vaccine does.
Edited by Faraz - 2/8/12 at 8:57pm
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post #90 of 94
Quote:
Originally Posted by aroc91 View Post

Nobody said it, alone, would get rid of the virus. The placebo effect has been demonstrated to increase immune system response in general, release endorphins, and raise body temperature, which actually does help fight bacteria and viruses, as they can be sensitive to higher temperatures; that's the basis for the fever response.

Placebo effect in a vaccine that will last for 3 years? Come on. You'd have to be dense to think that the placebo effect has any bearing in vaccine trials. These people aren't taking a new pain medication on a daily basis. They're getting an injection and wandering off for 3 years to see if they catch HIV, with maybe some boosters in the interim. They mine as well not bother with a placebo group- if anything the placebo group will have higher than average infection rates due to some idiots thinking they're immune and not taking precautions. Oh wait, that's the population they're targeting anyways.

Face it, this is ethical grey area, volunteers or not. Vaccine trials are always grey area because of the consequences of getting the placebo. In this case, if you get the placebo and catch HIV over the course of the study, there is no crossover trial for you. You're just another point of data and will die in 10-20 years depending on the healthcare available to you.

The ethics of drug trials are highly debatable, especially vaccine trials. You accept volunteers who meet your criteria, but you pay them. You inform them of the risks, and then you let them take the risks anyways. You give some the vaccine and some the placebo, but should anyone contract the disease, you have to treat them out of the research funding. There is to be no financial burden put on the subjects as a result of contracting the disease or any issues the vaccine may cause. This is an interesting read, straight from the WHO: http://www.who.int/vaccine_research/documents/ethics/en/index.html

All I'm saying is that I know double-blind clinical trials are necessary, but if the vaccine actually works even 80% of the time, a placebo group would not be necessary because the difference between number of cases in established statistics and number of cases in the vaccinated would be so huge. The placebo group here is to find out exactly the efficacy of the vaccine, which will have a specific percentage, which the drug companies will then consider if they want to use it or not. Necessary to see if the vaccine is worth it, but still letting people die. Like I said before, this isn't pain medication, once someone in the placebo group gets HIV there is no crossover trial for them.
Edited by KittensMewMew - 2/8/12 at 9:10pm
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