Novel drugs and pharma industry - a catch 22 situation

Success has many fathers and failure has none! Well, this adage is true in every aspect and surely holds water in pharma industry too. Whenever a new mechanism of action (MoA) of a drug shows promise, pharma companies bring their own version into their pipeline to be either “first in class” or be the “best in class”in that segment. But here is the catch. Not many of the new potential class of drugs (MoAs) have been studied carefully for a long period of time (~10 years or so) and hence scientific community as a whole would be in the dark to know what would happen if such drugs are in chronic use for a long period of time!

So, it is strange indeed, a kind of catch 22 situation. We need new drugs to counter diseases or disorders but we probably cannot wait to see the safety of these drugs for a decade to deem them fit for consumption! There have been many occasions when blockbuster drugs have been withdrawn after some time from the market when side effects were found to be profound. This leads to huge financial loss for the company involved and trust deficit not only in the company but also in the regulatory bodies which approve them in the first place. Of course, the loss of human lives or debilitating diseases associated in such cases cannot be weighed in terms of financial loss.

It is not that everything (I mean the potential side effects) cannot be predicted beforehand. We have seen that even when drugs in the pre-clinical stage have shown some glaring side effects yet these have been approved. Worse still, pharma companies sometimes hide such data on the garb of statistics and get around the approval door. But in the long run this leads to loss for such companies only!

Nothing in this world is full of positives and devoid of risks and so is the business of drug discovery. But what we need is rational understanding of novel MoAs and honesty before the pharma companies release their drugs into the market for human consumption.