Further Discussion on the Case Studies

Those of you who were in class today may continue the discussion of your group in Blackboard (your group should have a discussion area to itself). If you log in and don't see one in the discussion area (and were in one), let me know and I'll fix it. What I'd like is for you to work with your group to produce a short formal response to your research proposal, defending your particular stance, and indicating what questions would need to be addressed before the research was sanctioned. If you find that you're changing your mind from earlier, you might note and discuss that as well. Choose someone from your group to post your final verdicts here. At that point, I hope discussion will open up about the bigger theoretical and methodological issues. Remember, I made these up (including many of the background details), so don't go attacking the proposals on factual grounds. This is an experiment.

Here are the "Research Proposals":

Experimental Proposal J
Background
Malaria is a disease, spread primarily by the Anopheles class of mosquito, that presently kills millions of people around the world, many in poorer parts of the world where access to chemical prophylaxis (e.g., quinine, mefloquine) and physical prevention (e.g., screens) are much less available. The proposed research project involves assessing the effectiveness of a novel, inexpensive topical ointment in preventing the spread of human malaria by specifically deterring bites from the Anopheles mosquitoes, though at the cost of increasing bites by other mosquitoes that do not appear to carry any disease.

Methodology
Rather than test this ointment on human subjects, our research group proposes to treat a number of dogs with this ointment, expose them over the course of several weeks to mosquitoes, some of which are malaria carriers, and monitor the spread of the disease. Our hypothesis is that dogs treated with the ointment will show significantly less incidence of malaria than the control group. If this is successful, we will recommend immediate human trials and (pending successful governmental review) subsequent global distribution.

Experimental Subjects
While dogs are vulnerable to malaria, their symptoms are usually much less severe than humans — and rarely fatal. Unfortunately, usual palliative measures (quinine) are less effective. It is probable that only a few dogs will need to be euthanized at the conclusion of the experiment.
Due to the nature of the ointment, the animals will have to be shaved every day or so. While this is often uncomfortable and frightening, it does not harm them. The bites from the other mosquitoes they are likely to get (if the ointment is successful) will have to be administered to after the experiment is over, as the use of any itch-reducing ointment will likely interfere with the effectiveness of the experimental ointment.

Experimental Proposal K
Background
Malaria is a disease, spread primarily by the Anopheles class of mosquito, that presently kills millions of people around the world, many in poorer parts of the world where access to chemical prophylaxis (e.g., quinine, mefloquine) and physical prevention (e.g., screens) are much less available. The proposed research project involves assessing the effectiveness of a novel, inexpensive topical ointment in preventing the spread of human malaria by specifically deterring bites from the Anopheles mosquitoes, though at the cost of increasing bites by other mosquitoes that do not appear to carry any disease. Animal models have already shown that this treatment is approximately 98% effective in preventing infection.

Methodology
Human volunteers in areas high malarial incidence will be treated with the ointment and monitored over several months to determine whether this incidence declines. In order to speed the experiment, our group will select sites which, due to poverty, typically lack physical measures of preventing mosquito bites (such as window or bed screens). Nor can we offer any topical analgesics to help control itching due to increased bites from non-carrier mosquitoes, as these ointments have been shown to interfere with the effectiveness of the experimental ointment. If the success of the animal model is reproduced, we will seek governmental approval for immediate global distribution.

Experimental Subjects
Because of their location, the volunteers for this experiment do not face any greater risk of contracting malaria than non-volunteers. The known side-effects of uncomfortable itching due to increased mosquito bites, while uncomfortable and distracting are not unmanageable. Volunteers will be fully informed of the slight risk (<0.1%>Experimental Proposal L
Background
The so-called “placebo effect” (in which a biological inert agent produces a physiological effect because of the psychological expectation that the agent is a treatment) is well known. The biology behind this phenomenon, however, is not well understood. In particular, the effects of hormones on the neurochemistry underlying this effect are suspected to play a role. This study will help uncover this role.

Methodology & Experimental Subjects
The consistent and well-understood elevation of certain hormones in pregnant women provides an excellent test group to study the mechanisms of the placebo effects. By the very nature of this effect, it is not possible to fully inform volunteers of the true purpose of the study. Instead, volunteers will be gathered by offering an experimental treatment for morning sickness (which in some women is extreme). These women will be told that they will be “screened” for use of the new drug, when in fact some of the women will be selected as controls. These women will be told that because of a certain genetic marker, they are ineligible for the drug, but should return on a weekly basis for “rescreening” in case their status changes. Other women will be told that they are compatible for the treatment and will be given an allotment of sugar pills. They will also be asked to return weekly for monitoring.
Previous studies have shown that the placebo effect is greatest when subjects believe that there is some risk attached to the treatment. Thus, we will inform the women that there is a minimal risk (<0.1%)>