Canadians to start HIV vaccine clinical trials(ottawacitizen.com)
ottawacitizen.com
Canadians to start HIV vaccine clinical trials
http://www.ottawacitizen.com/health/Canadians+start+vaccine+clinical+trials/5890341/story.html
4 comments
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
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?
It is laughable to think that someone who funds research should be given an award. The people doing the actual research deserve an award leaps and bounds above and beyond the one providing funding.
I don't think you need to be so antagonistic against the funders. Not to mention that there are different awards for different things. I think it would be perfectly fine (and that all the members involved would agree) if the researchers were given the Nobel prize in Biology and the funders the Peace prize.
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.
Another option would be to name the actual vaccine after the funder.
Another option would be to name the actual vaccine after the funder.
> 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 thing it vaccinates against.
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 thing it vaccinates against.
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 a lot more individual and organized violence.
Dealing with HIV, a general explosion in commodities prices, end of the Cold War, and hands-off Chinese infrastructure investment (tied to commodities, but without trying to influence the government, and thus acceptable) has gone a long way to help Africa. Urbanization, IT/Communications (and access to regional/global markets), and foreign direct investment helps a lot too.
Dealing with HIV, a general explosion in commodities prices, end of the Cold War, and hands-off Chinese infrastructure investment (tied to commodities, but without trying to influence the government, and thus acceptable) has gone a long way to help Africa. Urbanization, IT/Communications (and access to regional/global markets), and foreign direct investment helps a lot too.
Thanks for the response, that was very informative.
[deleted]
Depends,
If you have a group of researchers truly dedicated to this cause that are out there working long hours and struggling to get the resources they need to solve this issue than yes they should be rewarded when their work comes to fruition.
On the flip side if you're just some lab rat making a salary and don't really care one way or another what genes you're slicing today as long as you're getting paid then what makes your contribution greater than someone that gave up a significant portion of their personal wealth to make something happen.
The real test here should be if someone has made a material contribution here because the thought it was the right thing to do.
If you have a group of researchers truly dedicated to this cause that are out there working long hours and struggling to get the resources they need to solve this issue than yes they should be rewarded when their work comes to fruition.
On the flip side if you're just some lab rat making a salary and don't really care one way or another what genes you're slicing today as long as you're getting paid then what makes your contribution greater than someone that gave up a significant portion of their personal wealth to make something happen.
The real test here should be if someone has made a material contribution here because the thought it was the right thing to do.
They are all doing a lot more than I am to fix the problem so either way, hats off to them.
Why?
Not implying this is the case here, but what if the research is trivial, but requires billions of dollars?
Not implying this is the case here, but what if the research is trivial, but requires billions of dollars?
> 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 vaccine? Unless I'm misreading this and "non-vaccinated" means placebo.
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 vaccine? Unless I'm misreading this and "non-vaccinated" means placebo.
A couple things:
1) We generally know the strength of the placebo effect and the rate of HIV transmission among at-risk groups, so we can control for it, and
2) Not sure the placebo effect is particularly relevant. First, a vaccine that shows little to no benefit over the control (placebo or not) is not an effective vaccine. Second, placebos aren't effective for everything. I highly doubt the effectiveness of a placebo at preventing HIV transmission (although it would be difficult to test ethically).
1) We generally know the strength of the placebo effect and the rate of HIV transmission among at-risk groups, so we can control for it, and
2) Not sure the placebo effect is particularly relevant. First, a vaccine that shows little to no benefit over the control (placebo or not) is not an effective vaccine. Second, placebos aren't effective for everything. I highly doubt the effectiveness of a placebo at preventing HIV transmission (although it would be difficult to test ethically).
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 kind of disease.
It would be unethical to give a placebo to someone for this kind of disease.
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.
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.
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 looking for. If they're looking for married, middle-age straight non-injection-drug-users, it's safety trial. If they're looking for young single MSMs or injection drug users, then you know that vaccine has progressed to the efficacy trials.
http://www.rochestervictoryalliance.org/
The 'non-vaccinated' group he speaks of is the placebo group. The reason he mentions it 'head off' anyone assuming they would test it by exposing people to HIV.
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 looking for. If they're looking for married, middle-age straight non-injection-drug-users, it's safety trial. If they're looking for young single MSMs or injection drug users, then you know that vaccine has progressed to the efficacy trials.
http://www.rochestervictoryalliance.org/
The 'non-vaccinated' group he speaks of is the placebo group. The reason he mentions it 'head off' anyone assuming they would test it by exposing people to HIV.
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).
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).
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".
"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".
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...
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...
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 there's a Canadian production facility which meets that).
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 there's a Canadian production facility which meets that).
>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.
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.
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.
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.
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.
I want new drugs to be developed faster and cheaper. This has very little to do with the profit of huge companies.
I really hope you aren't railing MDMA and shrooms...
This guy has been working on fighting one virus for almost 25 years. I can't quite compare what I aim to do with my startup to preventing HIV, but we certainly hope to have a massive positive impact on the world. So when I feel impatient about changing the world now, this should put things in perspective.