Drug
testingDrug
testingBefore a drug can be released onto the market, it must be tested thoroughly. Most medications go through years of trials on small mammals such as rats or mice. They are then opened up to human trials.
The two types of human trials are:
General trials are usually the first to occur. Volunteer patients (generally those who have not responded to other treatments) are prescribed the drug and are closely monitored. The patients know that they are on the drug, and their doctor knows they are on the drug. The patient will record their experience of the drug and this will be compared to other patients experiences. A general trial can use as few as one person, and is generally not very clear about the exact effects of a drug.
Double blind trials are much more accurate than general
trials, so much so that statistical analysis can be used on the results.
The group studied must be statistically significant (generally more than 50 in
human trials). The group is divided in two - half will receive the drug,
half will receive a placebo. (Placebo drugs are identical to the tested
drug in looks, but do not actually contain the drug...they are usually a
combination of lactose and sugar.) The patients do not know whether they
are receiving the placebo or the actual drug. As well, in a double
blind test, the administering doctors do not know whether they are giving a
placebo or not. This way, the patient and doctor will report any changes
caused by the "drug" not knowing whether it is actually the drug or not.
This is done because the human mind is an amazing thing, and if you believe
you are taking a drug, often you can get better even if the drug doesn't do
anything.
There was a case involving one medication where people on the placebo actually
got better faster than those on the drug!
This is where Tourette syndrome can come to a disadvantage.
All of the drugs prescribed for Tourette syndrome are
primarily used for other things. While most have been double blind tested
for use in Tourette syndrome, this usually occurs late in the release process.
So if I can use the example of the new drug aripiprazole; while it has been
thoroughly tested for schizophrenia, only small general trials have been done
for its effect on Tourette syndrome. The theory is that, because other
anti-schizophrenia drugs work on tics, this one will too...but it hasn't
actually been tested properly.
I may find over then next few weeks, that aripiprazole aggravates Tourette syndrome. Or it may affect the dopamine receptors strangely which, while treating schizophrenia, has no effect on Tourette's. So I find myself a member of a general trial. And yes, I am nervous.