Super-sucks to be in the placebo group on this one if the vaccine really works.
It reminds me of a study done in IIRC South Africa (although it's been a year or more since I heard of this so it could be anywhere in Africa really) where they circumcised a group of males to see the effect on HIV contraction and it was so great (due to HIV's severely limited lifetime outside the body compared to over viruses and bacteria's) that they ended up circumcising the control group.
Hopefully if this study goes well then they'll do the same. I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it for the sake of evidence for 5 years and let X-many people get HIV.
> I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it for the sake of evidence for 5 years and let X-many people get HIV.
This is wrong on so many levels.
First, until you conduct the trials have the evidence there is no guarantee that (a) the vaccine works and (b) that it isn't harmful itself. The idea of a guaranteed vaccine that hasn't been through trials is nonsense as trials are an integral part of such a guarantee.
Second, you can't sue someone for with holding such a drug unless you have some sort of basis in law to have that drug - basically a contract between you and the company. As the drug companies can't legally sell a drug that hasn't passed testing no such contracts exist. While I'm sure you'd like to exert some sort of moral right to the drug (and I'd kind of agree with you), a legal right which could form the basis of a law suit simply isn't there.
Third, why would a company sit on a vaccine for AIDS? Yes a majority of those at risk are in the third world and have no money but there is a market of hundreds of millions who could afford and would pay for a vaccine in the wealthy developed world. It simply makes no sense to suggest that they would do anything of the sort.
> I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it for the sake of evidence for 5 years and let X-many people get HIV.
Considering that all prior HIV vaccine attempts failed completely, sitting on it till they know for sure is exactly what they should do.
And, BTW all those vaccines also came with press releases that touted how great it was, and how sure they were that this time they got it.
Based on past history I would give this vaccine less then 10% chance of actually working.
You seem to be focused on success, but realistically the vast majority of pharmaceutical trials fail.
I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it
That's why you do this phase in poor countries. Duh.
For instance, contraceptives were widely tested in Puerto Rico in the 50's before being put on the national market in the 60's. They weren't initially sold in Puerto Rico, though, because there wasn't enough money in it yet. [Caveat: I don't know this from personal experience - it's common knowledge in Puerto Rico, but then it's common knowledge here in Indiana that Barack Obama is a foreign-born Muslim, so ... take it all with a grain of salt.]
It is well documented, this a good documentary about it [1]
And it was not the worst case. The US government infected people intentionally with syphilis and gonorrhea in Guatemala during the 40's to research about STD [2], last week the U.S. goverment was sued over those syphilis tests [3].
Note that in this case of circumcision the possible negative effects are well known, but a vaccine might have complications in X years that would not be worth the decreased contraction of AIDS. In hypothetical example, perhaps it increases the chances and severity of heart attacks by some ridiculous percentage.
In general, with medicine, it sucks to be on the wrong side of an experiment, but it can be difficult to know which side that is.
It's tricky: there is often monitoring of interim results for exactly this reason, but there are some good theoretical reasons to think that halting a trial on the basis of good interim outcomes in the experimental group could bias the results.
That was South Africa (I'm here). That wasn't a study on circumcision, that was nothing more than a statistical correlation, and one without any established causal relationship to support the 'prevents HIV' claim. There are many other factors to explain the correlation - cultural, economic and demographic.
Circumcision is still practiced as a coming-of-age rite here by many.
That was South Africa (I'm here). That wasn't a study on circumcision, that was nothing more than a statistical correlation...
Look again. There have been multiple studies. The ones most often cited were in Uganda and Kenya, and they were real studies. (If only single-blind for obvious reasons.) See http://www.niaid.nih.gov/news/qa/pages/amc12_qa.aspx for more details.
Your criticism is accurate for the South African studies. But we have better data today.
Getting a false positive result because you screwed your significance test because you decided to stop early? When you release it to the public, people think they're protected, so many more people than X die.
It reminds me of a study done in IIRC South Africa (although it's been a year or more since I heard of this so it could be anywhere in Africa really) where they circumcised a group of males to see the effect on HIV contraction and it was so great (due to HIV's severely limited lifetime outside the body compared to over viruses and bacteria's) that they ended up circumcising the control group.
Hopefully if this study goes well then they'll do the same. I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it for the sake of evidence for 5 years and let X-many people get HIV.