AIDS immunization, and an ethical question

[Segnosaur]

People may have heard that a vaccine against HIV has recently been tested. Unfortunately, the test failed, yet some groups (blacks and asians) seemed to have more response than other groups.
http://chealth.canoe.ca/channel_health_news_detail.asp?channel_id=16&menu_item_id=4&news_id=6064

Now, one thing that I had been wondering about (and the article touched on this)... is giving people an experimental vaccine always a good thing? Or might it encourage people to try 'risky' behavior, assuming they had been protected? (There are 3 possibilities... a person could receive a vaccine which works, one which doesn't work, or a placebo. 2 of 3 possibilities are bad, but people may assume that they will be protected when they're not.)

Any opinions?

 

[Jon_in_london]

could have a good point seg, but looking at the way people behave genrally, doesnt seem like it will make much difference. Tyring to get H. sapiens to not have sex is like trying to get a brick to fall upwards. I think what you have said applies to even a succesfull vaccine. We need and omni-anti-STD vaccine in any case.

Just tel them you may have got a placebo so- its russian rouelette with two rounds in the chamber.

Ahh... whatever.

 

[Andonyx]

Once the trial is complete, and data organized for susequent analysis, would it not behoove researchers to tell participants what they did in fact receive?

It seems to me that if they didn't, their medical history is incomplete, and that person may now be lacking serious information needed to make responsible decisions about their medical treatment in the future. Especially if they received a medication which may alter the effects of other medication.

 

[Ladewig]

I've seen ads for people who engage in risky behavior to participate in studies. I imagine that the first step in selecting these volunteers is to make them aware of the precautions that can be taken. The ones who say that they plan to continue avoiding these precautions are then selected for the study.

 

[Blue Monk]

I heard one of the researchers in this project interviewed yesterday on Public Radio and they touched on this subject.

The subjects in this case were given standard AIDS counseling and warned against any risky activity but given the vaccine nonetheless.

As a result many of the participants followed advice and abstained from any risky activity thereby negating their participation in the study.

The researchers knew, however, that not all people follow their advice and it was this group that was included in the statistics. They did not ask any participants to willingly forego appropriate safeguards and in fact urged all of the participants to abstain from all risky activity.

Also the ethnic results were unexpected but they aren't relying to heavily on the results as the tests were not designed with that in mind. In fact the study was conducted on predominantly white male homosexuals, not by design, but due to cultural reasons they were the most cooperative group and the lest skeptical of governmental research programs due to the fact that many knew individuals who have been helped in the past through chemo-therapy.

The actual number of non-whites and intravenious drug users was statisically very small, too small in fact to make any substantial assessment, but they have taken note of what the statistics do suggest and they plan to design future studies with the ethnic factor considered.

 

[spoonhandler]

Andonyx wrote:

Once the trial is complete, and data organized for susequent analysis, would it not behoove researchers to tell participants what they did in fact receive?

My understanding is that patients in clinical trials are informed, once the study is complete, what arm of the trial they ended up in. However, in some institutions/countries, it may rely on the patient's initiative to ask the research team for this information.

I think they did a good job in generating data from people engaging in high-risk behaviour without promoting said behaviour.

 

[Penrich]

I read this story on CNN. And see this version of the same story

The overall total reduction was quoted as 3.8% out of about 5400 people. That gives about 3.8 *5400/100 = 205 people who were apparently protected by the vaccine. There were 314 blacks in the trial, and the rate of protection is quoted as 78.3% amongst blacks. i.e. 245 blacks were protected (78.3 * 314/100).

Thus, out of the 205 people protected, 245 of them were black.

Haven't found the study published on PubMed yet either.

 

[garys_2k]

I read this story on CNN. And see this version of the same story

The overall total reduction was quoted as 3.8% out of about 5400 people. That gives about 3.8 *5400/100 = 205 people who were apparently protected by the vaccine. There were 314 blacks in the trial, and the rate of protection is quoted as 78.3% amongst blacks. i.e. 245 blacks were protected (78.3 * 314/100).

Thus, out of the 205 people protected, 245 of them were black.

Haven't found the study published on PubMed yet either.

I think you're mixing up your numbers. First, I seriously doubt that the overall "impact" of a 3.8% change was statistically significant, That is, it is likely that at the overall level, ZERO people were protected.

But, on a finer cut, we have 314 blacks in the trial that did seem to gain protection, but we don't know how that worked out. They quote a percent "reduction in infection" but you cannot just multiply that by the number of participants to get the number protected. If a total of 314 were in the study, and the numbers given the vaccine and placebo were even, all this says is that whatever portion of the placebo group got infcected, the number in the vaccine group that got infected was about three-quarters smaller.

However, if the real numbers of either the placebo or vaccine group was too small, than that is statistically insignificant, too. We should also look at their confidence level to see what they are calling "significant." Most studies use 96% (two sigma), but that's not clear here.