Pharma: Debating the ethics

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.)

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9 thoughts on “Pharma: Debating the ethics

  1. Is the TV show ‘House’? And was the doctor ‘Foreman’?
    I think I saw something similar there.
    Its the harsh thing but I dont think it really happens.
    Just in case, Dont get too close to your doctor.

  2. @Vivek
    Yeah it was House…the thing is that doctors do sometimes personalize their patient care, and view the trial as a tool to fix the patient with, it must be completely untainted as an experiment, or there is nothing to be gained from the data.

  3. I agree. For the trial to be an effective tool, should be completely untainted.For eg.the field of neuropsychology is one where hardly any progress can be made without placebo controls. I would go as far as to say that restricting the use of placebo only in cases where no proven therapeutic method exists is hardly justifiable. Neither the Declaration of Helsinki nor GCP are able to ensure that these trials are conducted without any emotional involvement. The revisions made to the declaration are futile as they attempt to only garnish the “food with different toppings” not emphasizing the need of integrity in such trials. The first duty of the doctor is towards his patients, but when there are millions relying heavily on the outcome of such trial, it is imperative that they are carried without any prejudice. I am not saying that we should behave irresponsibly towards the patients. Instead of rambling on over this “ethics” issue, we should try to find a way with everyone’s interest in mind. For instance, revising the “informed consent” form, so that the loopholes are eliminated.

  4. @Anon
    That was a nice contribution. Either you are a pharma person yourself, or a very well read one. Either way, your comments are most welcome on the blog! Informed consent is a topic on which I was planning to write another post altogether, would love more of your insights on that.

  5. There are specific rules that guide the conducting of clinical trials. Informed consent is an important component, however sometimes a patient enrolled in a trial is unable to provide informed consent, (for example, children, or mentally incapable etc). In terms of placebo, FDA states that “Placebos are not used if a patient has a serious illness that needs treatment. All people are told before they join a trial if placebos are going to be used in the study.” Sometimes, there is enough information about the drug even as the trial is progressing that the sponsor of the trial decides to stop the trial early, or get a seriously ill patient off the placebo (not possible in a double-blind randomized) particularly in case of some oncology trials. I just wanted to assure you that a lot of thought has gone into these things, and there is a lot more subtlety than a 45 minute TV show could possibly shed light on.

  6. @avalok ishwar
    The bit about the 45minute show was just to endear the topic to the layperson, but blinds are broken in certain cases. Informed consent is an important topic, and so is conflict of interest. It is underestimated in some cases. When you actually conduct a double blind, double dummy placebo controlled crossover study, one can expect some surety of the integrity of the process. This post was to emphasize the experimental nature of the trial for its probative value alone and not to treat patients, no matter how sympathetic their condition might be.

  7. Pingback: A post on the lack thereof | SNAFU

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