“Ethics is knowing the difference between what you have a right to do and what is right to do.”

–Potter Stewart

Drug designing is the inventive process of finding new medications on the basis of the knowledge of the biological target. For example, the structure of a receptor maybe known, a drug which has a structure complimentary and charge opposite to that of the receptor will interact with the receptor causing its activation or inactivation thus leading to a pharmacological response. However, the term drug design is a misnomer, drug design is nothing but designing of a small molecule that will bind to the receptor. Many other parameters of the ligand (small molecule) have to be checked and verified before it can be called a drug.

The Pharmaceutical market is rising in value as each day progresses. As the business grows, the laws increase but there are certain aspects which cannot be governed by the law and will always vary from a company to another and fall under the heading, ethics. As we discuss ethics in drug designing, it is important not to confuse this with ethics in clinical trials. Clinical trials are at a much later stage of the medicine production with drug designing being the very first.

With the computer doing almost anything and everything in today’s world, drug designing is no exception. The specifications and needs are fed into the computer and making use of high-end software like CADD (Computer Aided Drug Designing) a theoretical molecule is obtained which fits the needs. Now is the real challenge, putting the theoretical work into applicative purpose. This involves trying to synthesize the same drug molecule in the lab. Most of the pharmaceutical chemicals are non-biodegradable. Be it in the gaseous form released into the air, solid form being dumped in some corner of mother earth or liquid form which is just insidiously pumped into the water body around. Drug discovery takes a lot of years and countless number of trial and errors. When we think about this, our first question should be, what about all the chemically active wastes produce during the process? The lab synthesis may not have the activity we desire but may have other activity. The chemicals enter our environment and remain in it for almost unlimited period of time. There are documented proofs of the chemicals in our environment which have been present since decades and still continue to harm the microorganisms and wildlife in severe and unexpected ways. Trial and error methods may make use of various organic and inorganic compounds and specially solvents. What is the fate of these solvents? Do companies make it compulsory to treat any toxic effluents before they are discharged? Well, we could expect them to do that at their manufacturing level since the law may require them to do so but maybe not at the drug designing level. One may assume the volumes are too small and they are too less to cause any damage. But over a period of time, the amount is more than substantial. As there are thousands of different synthesized chemicals present at the same time in the environment, different interactions may occur and the result of these multiple exposure in human and nature are not sufficiently studied or understood. The damage from this has no end. Untreated waste today will show its effects for decades to come and then there is no turning back. Yes, drug designing is needed. We need new drugs to counter newer diseases or which may be cheaper alternatives to the ones already present. The need for newer antibiotics isn’t a hidden concern. But at what cost? This is a matter which probably no law can govern. It is a matter of ethics, a situation where you have to give importance to your role and contribution to the society and environment around you than just the short term money making selfish mentality which most of us have.

Where the earlier stanza discusses ethics in drug designing with respect to the environmental concerns, ethics during drug designing also play an important role from the pharmaceutical company point of view. To design a totally new drug, not only does it take sumptuous amount of money, it also takes decades of hard work and dedication by the researchers to develop one new drug design. Sometimes a new drug maybe developed successfully, it fits in all the theoretical criteria correctly but this drug fails in the clinical trials. This only goes on to show how unjust the process can be but it is still essential and a successful drug can go on save the lives of millions. In such a scenario, when a company develops a new drug and it passes the clinical trials, it has patent for it. That is, no other company can manufacture or sell the same drug for a stipulated period of time. This is a necessity since the company needs to recover the millions of dollars it might have put into research and this patent period also encourages further research. But there is a twist to this which is making investment into the R&D department unfavorable. Each active molecule has a specific structure. This structure is the one which gives the molecule its pharmacological activity. Once the company has discovered the molecule and its actions have been proved, it applies for the patent for that structure and then goes on further to launch it as a medicine post clinical trials. Now this drug is in the patent period and cannot be manufactured or launched by another company. But there have been cases in the past where, another company will take the same chemical structure of the molecule, take stereoisomers of the same structure or make other extremely changes such as replacing a methanol group with an ethanol one. In layman language, making very minute structural changes which doesn’t hamper the pharmacological action. This modified structure isn’t patented for and has the same action as the actual drug hence it can also be launched as a drug. This creates competition in the market and prevents the original company from earning what actually is its right. A drug has a very complex structure with various bonds and groups. There are almost infinite numbers of small changes that can be made and there is no law which can govern and prevent this from happening. However companies have now learned from this, when they apply for a patent for a new drug, they also tend to apply for a patent for drugs which may be obtained even with the smallest of structural changes. This minimizes the chances of other companies trying their unethical methods and even if tried, they might infringe the patent of the original company.

All said and done, certain issues will never be governed by the law and will always be up for debate with respect to its need and rightfulness and for such issues coming to a conclusion is extremely difficult because each person feels different with respect to these. However, people and companies are getting more aware about their role in the society. A company may be right according to the law but certain unethical actions do blemish the company reputation which it might have gained over a very long period of time. This fear keeps them from performing unethical actions. Hence I would like to conclude by quoting the words of Albert Campus, “A man without ethics is a wild beast loosed upon this world.” A person who believes in ethics and ethical methods of operation speaks large volumes of his selflessness and magnanimity. If all of us could follow the same someday, it will be a better place to live in.

Arjav Modi, Shayaan Khatib, Hetuk Shah

(Final Year B.Pharm.)

Tags: MET Institute of Pharmacy