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Canadians to start HIV vaccine clinical trials

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Re: Canadians to start HIV vaccine clinical trials

#21

Post by redthrowaway »

rdl wrote: post #12
baddox wrote: post #10

Why does Canada need permission from the FDA?

They want to make sure the trials are recognized by the FDA as well, so the resulting drug (if successful) can be sold in the US without repeating early stage trials. Outsourcing clinical trials to other countries (usually India or SE Asia) is one of the biggest advances in drug development in the past 20 years. The vaccine is also being manufactured in the US for these trials (it requires BSL3, and I don't think the…

>Outsourcing clinical trials to other countries (usually India or SE Asia) is one of the biggest advances in drug development in the past 20 years.

Not really what I'd call an advancement. It's being done because it's cheaper, the health and safety regulations are practically non-existent, and if something goes wrong then the subjects have very little recourse.

Re: Canadians to start HIV vaccine clinical trials

#22

Post by schiffern »

NolF wrote: post #17
schiffern wrote: post #16

Earlier quoted context omitted.

They're placebo controlled. It would be a colossal waste of money to do it any other way. Besides being methodologically unsound, the trials wouldn't be recognized by the FDA or Health Canada. The University of Rochester has also been working on HIV vaccines for many years. They're always recruiting subjects. The posters are interesting because you can see what stage this particular vaccine is at based on who they're…

There is no placebo group, it would be highly unethical to do so. Half the sample population gets the treatment half of it doesn't with the option to get the treatment once trial finishes. Changes in behavior due to treatment are accounted via survey pre-treatment and at measuring intervals.

You're mistaken: "Phase III would test the effectiveness of the vaccine in a larger group of about 6,000 volunteers who are at risk of becoming infected. Half would be given the vaccine and half given a placebo. Participants would then be tracked for three years to see how many in each group become infected." - http://www.ctv.ca/CTVNews/Health/20111220/canadian-hiv-vacci...

But more interestingly, why would it be "highly unethical" to do so? They're practicing informed consent, so everyone who gets a shot knows that there's only a 50% chance that they got the real vaccine. And they know that the vaccine isn't guaranteed to work (quite the opposite, in fact, based on the track record of similar trials here in the States).

Re: Canadians to start HIV vaccine clinical trials

#23

Post by ojbyrne »

defen wrote: post #4

> It will test how effective the vaccine is by comparing a vaccinated and a non-vaccinated group, Kang said in the video. So I was going to ask how clinical trials for vaccines are done, and this part kind of answers it, but now I'm curious - if there's no control group that gets a placebo injection, how do you control for the fact that people may behave differently if they think they've been given an anti-HIV vaccin…

My impression this is going to be something other than a pure scientific experiment (and I don't mean that in a bad way).

Medicine and social sciences have a large body of research about things like the fact that you can't do a pure experiment with a control group if there's serious risks.

http://en.wikipedia.org/wiki/Design_of_quasi-experiments

The seminal work (which I slogged through once upon a time): http://www.amazon.ca/Experimental-Quasi-Experimental-Designs...

Re: Canadians to start HIV vaccine clinical trials

#24

Post by ghshephard »

NolF wrote: post #18
ghshephard wrote: post #13

Earlier quoted context omitted.

The placebo effect is important because it might _increase_ rate of HIV transmission by resulting in more risky behavior. Or, it might reduce rate of HIV transmission by causing the person to focus on the possibility of infection more.

Both vaccine and non-vaccine groups receive appropriate counselling (this part can be double blind even) regarding HIV, risk behaviors, and as a trial vaccine it might no be 100% effective etc etc... You assess the impact of behavior changes via surveys and interviews to see if there has been a significant increase in risk behavior and the control for it. It would be unethical to give a placebo to someone for this ki…

Until the treatment is proven - it may turn out to be the case that the placebo is more beneficial than the treatment.

If you knew that it would be "unethical to give a placebo to someone" then you wouldn't have to do the trial!

Indeed - there have been situations in which the Trial turns out to be so positive - that the study is canceled, and all participants are given the treatment. I think that was actually the situation with the circumcision trials - circumcision turned out to be so ludicrously low risk, and so effective at reducing HIV infections in heterosexual male populations in Africa, that they, ethically, had to prematurely end the study and circumcise all the participants.

Re: Canadians to start HIV vaccine clinical trials

#25

Post by ars »

redthrowaway wrote: post #21
rdl wrote: post #12

Earlier quoted context omitted.

They want to make sure the trials are recognized by the FDA as well, so the resulting drug (if successful) can be sold in the US without repeating early stage trials. Outsourcing clinical trials to other countries (usually India or SE Asia) is one of the biggest advances in drug development in the past 20 years. The vaccine is also being manufactured in the US for these trials (it requires BSL3, and I don't think the…

>Outsourcing clinical trials to other countries (usually India or SE Asia) is one of the biggest advances in drug development in the past 20 years. Not really what I'd call an advancement. It's being done because it's cheaper, the health and safety regulations are practically non-existent, and if something goes wrong then the subjects have very little recourse.

That's the cynical reason.

The non cynical reason is that subjects in the US often take or have taken various other drugs. Depending on what they are checking those drugs may affect the results.

Re: Canadians to start HIV vaccine clinical trials

#26

Post by ars »

NolF wrote: post #17
schiffern wrote: post #16

Earlier quoted context omitted.

They're placebo controlled. It would be a colossal waste of money to do it any other way. Besides being methodologically unsound, the trials wouldn't be recognized by the FDA or Health Canada. The University of Rochester has also been working on HIV vaccines for many years. They're always recruiting subjects. The posters are interesting because you can see what stage this particular vaccine is at based on who they're…

There is no placebo group, it would be highly unethical to do so. Half the sample population gets the treatment half of it doesn't with the option to get the treatment once trial finishes. Changes in behavior due to treatment are accounted via survey pre-treatment and at measuring intervals.

You are contradicting yourself:

"There is no placebo group" vs "Half the sample population gets the treatment half of it doesn't"

The "doesn't" is the placebo group.

And since every single other HIV vaccine has failed, it's likely that this one will also - so it's not like they are withholding an effective treatment and acting "highly unethical".

Re: Canadians to start HIV vaccine clinical trials

#27

Post by loboman »

9oliYQjP wrote: post #2

Nobel peace prizes are not normally awarded to philanthropists. But I'm just going to leave this link here. It's a photo of Bill Gates with Prime Minister Stephen Harper announcing funding for HIV vaccine research in 2007. http://pm.gc.ca/grfx/news/PM-feature-20070220-Gates.jpg Source: http://pm.gc.ca/eng/media.asp?id=1544

Does Bill Gates care about this? I wonder how many of the Nobel Prize winners care about it really; they can be very proud about what they did already, who cares if somebody else recognizes them as important?

Re: Canadians to start HIV vaccine clinical trials

#28

Post by msbarnett »

rdl wrote: post #19
msbarnett wrote: post #14

Earlier quoted context omitted.

> That would be a great compromise -- an HIV vaccine would probably do more for world peace than at least half of the winners of that prize to date. What makes you say that? Improve the human condition and eliminate much suffering, absolutely, but do much for world peace? Has there ever been a war fought over HIV? > Another option would be to name the actual vaccine after the funder. Or, we could name it after the th…

HIV contributes to violence, civil wars, unstable governments, etc. in Africa. It's actually gotten a lot better in the past 10 years, but in the 1980s/1990s, there was a time when countries looked like they might collapse in the sub-Sahara due to high numbers of HIV/AIDS victims, orphans, etc. It was disproportionately affecting 15-35yo workers, and the fatalism caused by "will probably die from AIDS anyway" led to…

Thanks for the response, that was very informative.

Re: Canadians to start HIV vaccine clinical trials

#29

Post by rdl »

ars wrote: post #25
redthrowaway wrote: post #21

Earlier quoted context omitted.

>Outsourcing clinical trials to other countries (usually India or SE Asia) is one of the biggest advances in drug development in the past 20 years. Not really what I'd call an advancement. It's being done because it's cheaper, the health and safety regulations are practically non-existent, and if something goes wrong then the subjects have very little recourse.

That's the cynical reason. The non cynical reason is that subjects in the US often take or have taken various other drugs. Depending on what they are checking those drugs may affect the results.

Making it cheaper (and thus allowing more drugs to be tested, or to allow inventors to raise less money and thus keep more equity ownership, thus being better able to develop future drugs) isn't really cynical either, IMO.

I want pharma companies to make huge profits. I just want them to create vastly more surplus value for society in the process, vs. live via regulatory capture. If I could pay Novartis $10k/yr to be totally healthy and do fat lines of coke/mdma/mushrooms every day with no exercise, and have a 200 IQ as a side effect, I'd be quite happy.

Re: Canadians to start HIV vaccine clinical trials

#30

Post by asdkl234890 »

rdl wrote: post #29
ars wrote: post #25

Earlier quoted context omitted.

That's the cynical reason. The non cynical reason is that subjects in the US often take or have taken various other drugs. Depending on what they are checking those drugs may affect the results.

Making it cheaper (and thus allowing more drugs to be tested, or to allow inventors to raise less money and thus keep more equity ownership, thus being better able to develop future drugs) isn't really cynical either, IMO. I want pharma companies to make huge profits. I just want them to create vastly more surplus value for society in the process, vs. live via regulatory capture. If I could pay Novartis $10k/yr to be…

I want pharma companies to make huge profits.

I want new drugs to be developed faster and cheaper. This has very little to do with the profit of huge companies.

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