In class we
talked about the controversy behind the AIDS treatment in the developing
countries. In the United States, the 076 regimen has been tested with a
control, and was determined that it can decrease the transmission rate of AIDS
from mother to child. This treatment requires the injection of intravenous
drugs, some oral regimens, and the refrainment from breast feeding. However,
this treatment is expensive, and many people in the developing country cannot
afford it. Thus, there are other treatments that have been developed for these
countries, but the treatments have not been tested with a placebo experiment. The
debate is then whether or not we should test the treatments on these countries.
According to the
Declaration of Helsinki, physicians should not conduct experiments on patients
if there is known to be a better treatment. Here, the 076 provides such proven
treatment. Is it then ethical to give placebos to people?
It is suggested
in class that it's possible to data mine, and we can estimate the actual
transmission rate in the country. Therefore, without the use of placebo, we can
still guess at the effectiveness of the drug based on the evidence that we
have. Because data shows that there is a decrease in transmission rate with the
use of the drug in the countries we have data for, it is very plausible that
people in Uganda will also respond to the drugs in the same way. However, what
happens if there are significant side effects to the drugs?
Suppose that we
base on the current data and only provide drugs to the people without first
testing with placebo. Then, if significant side effects were to occur after
using the drugs, who should be responsible? I believe we should have an experiment
to make sure the drug is effective first. Perhaps the climate in Uganda is
different from the other countries, or maybe its society works in a way such
that the drug is ineffective. There are many reasons why a treatment can have
different results because we simply do not know the full extent to how our
bodies work, and there are too many factors that can complicate the treatment.
Therefore, I support the use of a placebo experiment using this drug, with the
consent of the people, and only after the drug is shown to be effective in
Uganda should it be administered.
1 comment:
Ben, I strongly agree with you that there should be no opposition to trials in which the results of the proposed affordable treatment are compared with a placebo. But my reasoning is slightly different from yours.
One of the main arguments against these trials is that the researchers conducting the trials are violating the Declaration of Helsinki because they are not comparing the proposed treatment with the best known treatment, thereby being unfair and unethical to half the total number of subjects (who would end up getting the placebo). My counter to this argument is simple, and is along the lines of the letter that Edward Mbidde, the chairman of the AIDS Research Committee in Uganda, wrote to the National Institute of Health. What he said in this letter was that the research was completely ethical simply because it was being conducted by the people of Uganda on the people of Uganda. And that is precisely my point. All subjects enrolled for the trials had all given informed consents, and the trial procedure was continuously being evaluated by local and foreign institutional review boards. How can it be unfair/unethical if the person who is undergoing the procedure has himself/herself chosen to do so?
Some might argue that it was unfair because given a choice between trials with a placebo and trials that use AIDS Clinical Group Protocol 076 as the control, the subjects would have chosen the latter. I do not deny that the subjects would have chosen the latter, but the point here is that the choice doesn't exist. This is because 1) Using the AIDS Clinical Group Protocol 076 as the control would cost over a thousand times more than using a placebo and 2) Scientifically, the placebo-controlled trial is much more likely to produce conclusive results. Hence, quite clearly, if we stick to the placebo-controlled trials, more experiments can be done using the available money from NIH and other US agencies, and better is the progress towards an affordable treatment for the prevention of the transmission of AIDS from an infected mother to her child. In other words, placebo-controlled trials would enable us to reach the affordable solution way faster than the 076-controlled trials. And because countless mothers and their children in Africa stand to benefit from this children, the fastest way must be the best way.
Sources:
http://www.nejm.org/doi/full/10.1056/NEJM199710023371411
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