MEDICAL TRIALS: ARE THEY WORTH IT ?

                       If you visit a government website www.clinicaltrials.gov of the US government, you will notice that whenever clinical trials are held in the world, they are first registered. Before the trial, you tell that you are going to conduct this trial, and people volunteer by giving in writing that the trial can be conducted on them for the sake of financial gains. Then the trial of the medicine is conducted. The trial has a rule that you have to submit in one year whatever the results may be and get them published in a medical journal. Those who conduct the trial are just businessmen; their work is, if trial is successful, it will be published and the published report will be submitted to the government, to FDO; and FDO will give the approval on the basis of the report that it can be sold for use by human beings and then it becomes a business. This is the model in the world. 

                      Whenever you want to introduce a medicine, you need to show the clinical trial and register. When you find a new drug, you have to prove through the trial that it is working most of the time. So like the coin you conduct several trials; hide the negative trials and don’t get them published. Because you yourself are conducting the trial, the control is in your hands. You don’t get it published but register it in the beginning itself. Without registration, trial cannot be conducted. While registering, you are not aware of the result. If the result is negative, you don’t get it published and just do away with it. In 2012, all trials were collected and it was revealed that ever since FDA has been formed, 50% of the trials have not been reported. Then those trials were tracked. It was known that 95% of the trials are those which were not reported since they showed negative results. If those trials were also included then, not even a single medicine that you know or use today, would be available in the market. 

                      Suppose I prove that it is head, it passes the trial and starts selling in the market and you start using it. I hide it from the government, from FDA but actually when you use it, will you always get a head? The result will be clear. By the time the result is explicit, quite a good amount of time would have passed, and I would have earned a huge amount of money, then what would the government do is simply ban it. 

                     The process of banning any medicine in medical industry is quite a lengthy affair. The average time to ban a medicine after being approved is 16-18 years. A medicine is introduced in the market but the adverse reaction of the medicine is reflected in 4-5 years. The adverse reaction of the medicine you consumed today would be reflected a little today in the form of may be loose motions or headache or stomachache or weakness or allergy but the actual adverse reaction will be known may be after four-five years. Till then lakhs of people would have consumed that medicine and would be in the grip of adverse reaction. That adverse reaction is reported and after reporting, FDA will take a couple of years since it has its own process. After verifying the reporting, and after applying the law, and then banning the medicine, the entire cycle takes 12-16-18 years. 18 years is a long duration to convert a medicine into business. After that, it will become a generic drug and will be of no interest to the company. Till then, the company would have found out several other medicines and marketed them. This is the truth. 

                       All of you are taking some medicine or the other-most of the time it is preventive medicine- for heart attack, Blood Pressure etc. Here I would like to say is that you are alive not because you are taking the medicine; I am surprised that even after taking the medicine you are alive. I see that the patients, who approach me, have been taking 19- 20 tablets for the last 10 years or so, I am surprised that they are still alive. We have three days here for interaction. Three days are enough to get the result. For example, today on the first day, we have the topic Diabetes and Hypertension-cure through lifestyle modification. If today, you quit the medicines for Diabetes or Blood Pressure, which you have been taking for the last 10 or 15 or 20 years, what will happen? If you do so, the companies will close down. I can assure you that nothing else will happen.

By Mr.Dr. Biswaroop Roy Chowdhury