An... "interesting" medical trial

[Thersites]

(if this is in the wrong section, go right ahead and move it)

Mainstream press:
http://news.bbc.co.uk/2/hi/health/8408108.stm

A major trial of a vaginal microbicide has produced no evidence that its use reduces the risk of HIV infection in women.
The gel, PRO 2000, is intended for use before sexual intercourse to help reduce HIV infection.
It was tested in a trial involving 9,385 women in four African countries.
The risk of HIV infection was not significantly different among women supplied with the gel than in women given a placebo gel.

It was hoped microbicide gels would prove to be an effective way to limit the spread of HIV, as experts admit that condom promotion alone has not controlled the epidemic.

And commentary:
http://www.catholicculture.org/comme...tr.cfm?id=5176

Got that? In order to gauge the effectiveness of the trial microbicide some of the "participants" were given a substance with no medicinal properties whatsover -- a placebo -- with the instruction to begin or resume sexual relations in a population with a notoriously high incidence of HIV infection.

To put it bluntly, the "lab rats" in this experiment were human beings with human hopes, loves, fears, responsibilities. Keep in mind that the participants necessarily had to be uninfected women at the outset of the trial. It is undeniable that the researchers wanted the women to be inseminated by men infected with a lethal disease agent. The trial would be pointless otherwise.

The ethics of this study are questionable to say the least. Some 9,000 African women were given a gel - and not a few placebos- and sent out to test it. Testing this gel would involve intercourse with HIV-infected persons. In that respect, the women who received placebos were essentially told to go out and contract HIV. And it turns out that the gel was useless anyway, so we have some 9,000 women who have been exposed to HIV who probably would not have otherwise. I mean, there's only so much I can say that the second article didn't.

[Teluog]

This is like testing out new airbags with live persons instead of dummies, where half of the vehicles don't actually have airbags, and the airbags in the other half don't work.

Is there no other way of testing this gel out?

[Jedidiah]

But they are only foreigners, eh?

[Teallaura]

Locate the study and read it. They should have counseled both sets of women on prevention then followed for a long period of time. What they are looking for is a reduction among the experimental group relative to both the control and the pop at large. It should be a statistical survey which is looking at a potential reduction in a pop already at risk. There's nothing unethical about that as long as all receive prevention counseling and are fully informed about the nature of the study.

The exposure is presumed from the prevalence. In a high prevalence area that's a reasonable presumption. No one should be sent out with instructions to engage in high risk behavior but the reality is that single event counseling is of only limited effectiveness so it's a valid presumption that some percentage of both your experimental and your control groups will be exposed and that those percentages are likely to be similar as long as the groups are randomly assigned. That's not unethical.

What would be unethical is not studying the efficacy of a potential prevention device before unleashing it or stashing a promising device/drug/vaccine rather than even trying to study it. Personally, this one sounds bogus to me - it's not exactly the first time 'round this block - but unless they did something to deceive the participants or to encourage risky behavior the charge of ethical violation is completely bogus.

Read the danged study then evaluate it. Studies should never, ever be analyzed second hand. If the researchers behaved unethically, then go after them, but if not, leave them alone.