Know Healthcare 2 - Clinical Trials

Clinical Trials: Steps followed in drug development before releasing the drug to market and making it generally available.

This is the main reason behind why your medicines cost a lot and I am sure you will agree with pharmaceuticals about their costing after you know what it takes to get a medicine out to market.

1) In US a patent you file for a new kind of medicine will expire in 20 years, which means after 20 years any one can reverse engineer the technology and produce it without patent restrictions

2) Any drug company when they roughly know, they have a workable concept for a medicine, will patent it first.

3) After patenting they will usually begin with say 1000 potential compounds (chemistry of the medicine) for the medicine

4) Out of which after a detailed study they will come down to say 500 compounds based on initial safety, storage, mass production capabilities etc. By mass production capabilities I mean, say you find one medicine that can cure a disease but if it takes 20 yrs to make one because of the rare nature of the compound used, what is the use?  So, the compounds they choose should be very widely available and should support mass production (say million tables in a day).

5) Out of the 500 they do trails on guinea pigs, monkeys and other animals first to see how it affects them. After this they will end up with say a 100

6) Next is testing on a very small group of people, say 10 at a time. They will be observed for any side effects and how the disease reacts to the medication.

7) Now they will have 10 compounds and will test that on a bit larger group of people- volunteers 

8) In all the above said steps there are lot of government restrictions and regulations that they have to satisfy, which I safely skipped mentioning .After all these they will have one compound they can take to market  if they are lucky enough

The interesting thing here is the points from 3 to 8 takes a good FIFTEEN YEARS off the total 20 year patent period and in addition to this they spend hundreds of millions of money during this term.

Guess what?

They have to see revenue in the remaining 5 years before others start reverse engineering it. That’s the story behind the costing.

Secondary usage of health records is a key answer to reduce the years of clinical trial, we will see what Secondary usage means, soon...