Random (placebo-)control studies, particularly double blind ones (where neither the test subjects nor treatment givers know who is getting the placebo and who is getting the experimental treatment) are considered to be the gold standard for determining medical efficacy and safety and for gaining knowledge in medicine (and in other fields). Consider the following:
1) Read “Hazardous journey: Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials Download Hazardous journey: Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials” and discuss what it implies about the necessity and desirability of random control studies.
2) How should we account for placebo-effects, since aren’t they actual effects? One study “Placebo treatment versus no treatment (Links to an external site.)” indicates there is no significant difference between placebo treatment and no treatment at all, seeming to me to indicate there is no real “placebo effect”. If that is the case, then why do we need placebo ‘control’ groups instead of just comparing the results of those who receive the experimental treatment with people in the past who have not received it?
3) Even if there is a placebo effect, isn’t it then an actual effect, so again, why not compare those who receive the experimental treatment with those who have not received it?
3) Read Allan Brandt’s “Racism and Research: The Case of the Tuskegee Syphilis Study”. (Links to an external site.) Treatment was withheld from black men with syphilis to see the effects of doing so, and it was (correctly) considered to be scandalous, though perhaps for some incorrect reasons as well as correct ones.
[People of long-time African descent and those of long-time European descent do have some different medical characteristics in part possibly because of ancestral exposure to different conditions or diseases that altered the immunity gene pools through natural selection for descendants, so it is not necessarily racist to do separate studies differentiating racial groups any more than it is sexist to study the differential effects of pharmaceuticals on men and women. (For a long time, women were not allowed to be tested, and men were used as test subjects for treatments then applied to women, to the detriment in some cases for women patients.) For example, those of African descent are more susceptible to tuberculosis than those of European descent. TB existed in Europe long before it did in Africa, and it is put forth theoretically that those Europeans most susceptible to it died, while those with some immunity or resistance to it lived to pass on those immunity or resistance genes. Those of long-time African descent are thus supposedly immune-wise genetically more like the population of Europe prior to its decimation by TB and are thus, supposedly, on average, more susceptible to it (see, for example, www.sun.ac.za/englishInaugurallectures/Inaugural%20lectures/InauguralLectureProfEileenHoal.pdf (Links to an external site.)).]
But the question here is, apart from any racism involved, how was withholding treatment from the Tuskegee syphilis sufferers different morally from withholding potential treatment from those in any control group, particularly where the outcome of withholding the experimental treatment is pretty much known from historical experience? Now, to be sure you understand which way I am asking this, I am not asking whether the Tuskegee study was justified, but why, since it was clearly not justified in the way it was done, control groups today are considered necessary for good evidence-based medical knowledge. Why are control groups in medical research today not as scandalous as the withholding treatment from syphilis sufferers in the Tuskegee study?
And for your further consideration of a case that seems similar in some way:
On March 29, 2015, 60 Minutes broadcast a report on research at Duke university to treat glioblastoma, a brain cancer that is one of the most deadly, and previously unsuccessfully treatable forms of cancer. The research treatment uses a modified polio virus injected into the tumor, which does some damage to the tumor as it attaches itself to the cancer cells, but the primary destruction of the cancer comes from the body’s immune response to the polio virus and what it is attached to. The first two patients had their tumors totally disappear, leaving the patients cancer free. For the third patient, the dose was modified, and that patient had a severe brain inflammation response to the increased amount of polio virus, couldn’t continue the treatment, and died.
The question here is whether it was morally right for them to change the dosage, given their prior success. Does it meet all the codes, regulations, declarations, guidelines, and principles of research ethics? And if so, does
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