In 2000, the American Journal of Public Health published a commentary on issues surrounding clinical trials of vaginal microbicides.
One of the goals in developing vaginal microbicides is to put control into the hands of women who may not have the power to require the use of a condom.
The use of vaginal microbicides as both a contraceptive and anti-STI agent is controversial, as some cultures may prefer the inclusion of a contraceptive effect, while others may embrace the anti-STI effect but avoid the microbicide if it also had a contraceptive effect.
The crux of the commentary is the amount of time a clinical trial takes when condom counseling is included, and whether this increased time increased the ultimate risk of a population of acquiring HIV. Studies that include condom counseling take much longer because it takes longer to demonstrate a difference between treatment arms if most people are using condoms, thus costing considerably more while not necessarily being safer.
“It is commonly considered unacceptable to recruit volunteers for a placebo-control study without first treating their STDs and counseling them to use condoms as the optimal protection against HIV infection. At first sight, this interpretation of ethics appears compelling and necessary; when followed through, however, it raises some complex issues and the protocol can even be seen to be counterproductive… Given that an effective microbicide can eventually be developed, how many otherwise preventable deaths might result form the delay caused by a strict interpretation of beneficence and justice during the trial period?”
The article goes on to question whether beneficence has to include the group participating in the trial or whether it can be a ‘parallel group’ of people, and whether the group of people participating in the study should be asked their opinion of which study design makes more sense. The article concludes that when condoms are provided, the same number of participants are exposed to possible risk, but the selection for the risk is different (self-selection for those who choose not to use condoms).
Which is the more ethical choice, putting some people at risk now for the future benefit of many more, or running ‘safe’ trials with counseling on condom use for all participants at the potential cost of many deaths prior to the approval of an effective vaginal microbicide? Do the researchers get to make that choice, or must they include the choices of the participants?
1 comment:
While I understand that we cannot learn the effectiveness of microbicide without putting it through a trial where the participants are not using other forms of contraception and STD protection, I think the consequences to the participants are too severe if a placebo trial is done. Women would get pregnant, HIV, HPV, along with all the other STDs would spread easily. We cannot allow that to happen.
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