Disheartening

The BBC reports:

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. New ways of curbing the spread of HIV are badly needed, particularly in sub-Saharan Africa, where nearly 60% of those infected with the virus are women. Women are often forced to take part in unsafe sex, and are biologically more vulnerable to HIV infection than men - so in theory a gel they could apply themselves could be effective.

A previous, smaller trial suggested PRO 2000 could reduce the risk of HIV infection by 30%. But the latest study, carried out by the Microbicides Development Programme, a not-for-profit partnership of 16 African and European research institutions, failed to find any positive effect. And the researchers say the trial was large enough to provide conclusive results. The women who took part were given the gel together with free condoms and access to counselling about safe sex.

Lead researcher Dr Sheena McCormack, of the Medical Research Council, which part-funded the study, said: "This result is disheartening.

"Nevertheless, we know this is an important result and it shows clearly the need to undertake trials which are large enough to provide definitive evidence for whether or not a product works."

Professor Jonathan Weber, from Imperial College London, who also took part in the study, said: "It is unfortunate that this microbicide is ineffective at preventing HIV infection, but it's still vital for us as scientists to continue to look for new ways of preventing HIV. "Now that we know this microbicide is not the answer, we can concentrate on other treatments that might be."

Diogenes adds:

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.

We are not told how the women in question were induced to comply (it is reported that they got "free condoms and access to counseling about safe sex"). It is all but certain that they were not truly brought to understand and accept 1) what a placebo actually is, 2) what each woman's chances of using an inert and useless substance were, 3) what the range of likelihood was for the trial medicine's being effective or ineffective. It is hard to imagine that 9,000 volunteers could have been assembled without some blurring of the truth.

Well, it turns out that the trial gel has no discernible effect in reducing the transmission of HIV. The reaction?

Lead researcher Dr Sheena McCormack, of the Medical Research Council, which part-funded the study, said: "This result is disheartening."

Bully for you, Doc. I trust the women in the study whose subsequent infection helped you draw your conclusion are equally stoic about the results. Let me go further: did you, Dr. McCormack, "field test" the gel with your own body in the same sub-Saharan circumstances? Did you ask your research colleagues or their wives and daughters to do so as well, for the sake of scientific progress? If, on the other hand, you were unwilling to put your own European middle class professional immune systems on the line, do you not feel a certain uneasiness at the "asymmetry of consequence" between your clinical discouragement and the discouragement of your, ahem, test population?