For the uninitiated, a clinical trial is pretty much a study of a new drug or formulation in humans. Before this, the drug/medication has been tested in animals which progressively go up the evolutionary scale to make sure that our principle has some modicum of proof. These trials usually have three phases which when complete and analyzed lead to a decision as to whether this medication does what it purports to do and is safe for use in the intended dose.
These trials are usually conducted in large hospitals where the subjects are lined up and then administered the drug in some form. In the initial stages, the drug is tested on healthy subjects, and when it is proven not to cause any adverse effects that completely preclude its use, the drug is tested on actual patients.
Placebo effect is the effect of the patient’s knowledge that he is getting treated, on the improvement of the patient’s condition. This might seem negligible, but some diseases have huge psychological components, which might be assuaged by the knowledge that a person is being treated. Hence, each trial will also have a bunch of people getting no drug at all, but just a placebo, which means that if this person shows signs of getting cured, we cannot completely rely on the medication curing the patient. In other words, such a placebo effect will reduce the veracity of the hypothesis that the drug actually cures the ailment it is supposed to.
There are many ethical issues with clinical trials. The one I wanted to focus on is the fact that there are large numbers of patients who are getting nothing but the placebo. These people might be dying from a hitherto untreatable disease, and might be pinning all their hopes on this experimental clinical trial. Even though their presence in this trial is futile to them, they are invaluable as they provide the baseline on which the positive results of the drug can be measured.
I saw a TV show about doctors in a hospital where a doctor conducting a clinical trial actually moved a patient from a placebo to the real drug because he knew her. Let’s not even bother with the doctor’s intention behind this act; it is enough if we focus on the fact that the integrity of a clinical trial was thwarted. The idea that this could actually happen in real life gives me the shudders.
Now I am not usually given to episodes of technical ramblings to an audience that is mostly not part of the pharmaceutical field.
The fact is that clinical trials, like other experiments, are to be taken objectively, without passion or prejudice. These placebos help enforce those rules. If we care about the few hundreds or thousands who might be hard done by in this trial, we are risking a potential patient pool of millions. When one swallows a pill of a drug that can save a life, or cure a small affliction, one must take comfort in the hours and hours of hard work and sacrifice that it takes to make it safe enough so that you can just pop it in.
It is true that pharmaceutical companies are colluding with each other within the competition so that they reap huge profits, but one must realize that these are the outcomes of successful products. So, the interests of the companies and the people are aligned in some warped way. To stop the druggernaut from burning a hole through the common man’s wallet, we have regulatory agencies which are there to oversee the situation.
While I would not go so far as to say that the pharmaceutical field is noble, I do hope that this small piece has mounted at least a small defense to the ever-piling accusations.
(PS: This post has a certain synecdoche effect in that the ethical quandary of a clinical trial is then extrapolated to the pharmaceutical industry as a whole. I hope my readers were not bored with this technical post, and I hope I have made it simple enough for the layperson to grasp.)