Are people really being made Guinea pigs? by Boppana Sujwal

About the author- Boppana Sujwal, pursuing M.B.B.S in All India Institute of Medical Sciences, Bhubaneswar; and have written a research paper which has been accepted by Indian Council of Medical Research(ICMR),Member of Institute Innovation Cell(IIC). Email: persuko@gmail.com

Are people really being made Guinea pigs?

No, I don’t think so. So let me give you a little context behind why this question is being asked, I have read an article in The Hindu criticising doctors, researchers, scientists and many others related to it for using man as a Guinea pig in various clinical trials.Before explaining my answer and talking about the article, let me give you a brief idea about the procedure to introduce a new drug or vaccine into the market. After doing an extensive research about the chemical formulation and possible pharmacokinetics and Dynamics of the drug in a laboratory, the drug is prepared this is called Drug designing and after that it is subjected to the following phases of a trail:

1. In-vitro studies 2. Animal testing 3. Phase I 4. Phase II 5. Phase III 6. Phase IV In these phases the drug is introduced to starting from cells, tissues, organs synthesized in the laboratory and then observed for the possible outcome. After that it is introduced into animals(like Guinea pig) and any adverse outcome is immediate noted and the drug trial is stopped. If a positive outcome is observed it is then introduced into a small group of humans(like 20 -100) who volunteered to the study and only after a proper informed consent is taken.This process continues further into large groups and then if good results are seen, it is introduced into the market and after that feedback is taken in the post marketing phase called Post marketing surveillance, for any new adverse outcomes.

This is in brief about drug trails. This is only the initial part of the story after that there are many clinical trials, randomised clinical trials and finally meta analysis.

Now coming to my comments about this, it isn’t right to call that people are being made Guinea pigs for these trials because a lot of research, study and may be discovery is behind a simple pill we take in our daily lives. Regarding the people who are involved in the phases before a drug is released into the market, before the phase involving humans the scientists, doctors and others have a brief idea about the effects of the drugs because of the phases before this like testing on tissues, organs, animals, so there is maximum probability that there is only minimum or sometimes no harm being done to them but as you know humans are different from animals even the closely related ones, so there might be some chances that an adverse outcome is observed for which nothing can be done except to treat the volunteer and the study is stopped,all these things need to be clearly explained to the volunteer and then an informed consent is taken before he is subjected to the trail.All these phases and testing are necessary for a drug to be introduced otherwise there might be severe consequences involving many casualties. So people who are criticising these things,need to remember that it is for a greater good, a single drug or a vaccine can help to save millions of lives . Remember or search how people used to suffer from smallpox or polio, with these vaccines now I can say at least a billion of total population has been saved from these deadly diseases.One needs to remember that every human body is unique, the same pill works differently for different people[ for example the same Dolo-650(PARACETAMOL) which is commonly used for fever undergoes changes of different magnitudes in different human bodies when taken ]so there is not a definite way one can be sure of how drugs work on a particular human. So these trails at least help is predicting and giving an idea of how these work on majority of population not all.I also acknowledge that there are various unethical trails or the trails which are not permitted to conduct in developed countries are being conducted in under developed or developing countries. These need to be identified and reported by the people and to be taken care of by the government. People need to read the consent thoroughly ,only then it is to be signed. Gullible people can be easily exploited by an uninformed consent.I also like to address a line in the article ” A Doctor prescribed tests of heart when I took my child with cough and fever , isn’t it absolute exploitation for my money?”. I hope he has done those tests and if not I pray to God that his child is still alive because that doctor isn’t mad or less knowledgeable than that person making those comments as there is an absolute relationship between throat infection and heart disease ,read about Rheumatic Heart disease which has consumed the lives of many children in developing countries. There are many things like this which are interconnected to each other which a common man may not know. Not all doctors are alike and don’t blame the entire profession of doctors for one bad person in the field,not every person in any field are good, there will be some misfits is every profession.

To summarize I would request the people who criticise these drug trails to remember that every vaccine you give to your child , every medicine you use to treat your family has passed all these trials , don’t be a hypocrite and blame others while using the product of their hardship . I’m sorry that our human bodies are different and unique to each other, if not these trails would be unnecessary. Please spend a significant amount of time in research about a particular topic you want to talk about and then you may freely express your opinion.I had to squeeze in a lot of information so I definitely might have skipped some details. For any information or a productive debate you are very welcome.

Thank you.

Boppana Sujwal.