Aside from illegal intoxicants, rarely any light gets shed on the production of pharmaceuticals. Having attended a lecture at Kings College University given by a Glaxosmithkline (GSK) representative, I was in a more able position to understand the long and arduous procedure of getting a drug from a simple compound to a tablet in your medicine cabinet. And this is what it entails:
After extensive market research, a drug company like GSK will see a demand for a certain undiscovered cure to a certain illness. Using what scientists know from knowledge, they come up with a large array of compounds that have the potential to become the cure.
The first stage is the Pre-clinical (basically, before testing on humans) testing which involves testing the compounds in in-vitro (in petri dishes) and in-vivo ( animal testing). This will make clear any toxicity to cells from the compounds as well as see if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction.
While preclinical testing is quite cheap, fast and highlights the few more realistic potential compounds, it does however have many issues. Cells or organs on their own are not fully representative of the possible side effects on the whole body and animal testing isn’t as reliable due to humans being different as the infamous case of the Thalidomide drug showed. Also a problem is the ethical issue of animal testing, which while legalised in most countries is still highly controversial.
Next stage is the formulation. The remaining potentials must be relatively easy to get ingredients for and manufacture on mass scale. There are many factors to be considered; shape, name, immediate or slow release, cream or tablet, storage requirement, shelf life etc. These factors are considered and the compounds that come out as most suitable proceed to the next stage.
Next comes the clinical trials. These are both money and time consuming steps yet are vital to the drug’s development. Healthy and hopefully, willing volunteers in small numbers are used and given the drug or a placebo and are monitored extensively for many weeks. The main drawback of this testing stage is that these are healthy volunteers and in small number which make it very misrepresentative albeit useful in finding side effects. You also find out the Pharmokinetics (drug absorption, distribution, excretion) and Pharmodynamics (effects on enzymes, blood pressure).
Following this is patient studies. This involves patients suffering from the given illness and this gives the developers an idea of effectiveness of the drug and the therapeutic window. Therapeutic window in simple terms is the minimum and maximum dosage. More patient studies follow this and these are on much larger scales. The developers also aim to compare their new drug to the current ‘gold standard’ and show how it’s better than its competitors.
The drug is then subjected to post marketing and to root out the final compound that will be sold. The limit to the whole process is that it is market driven and thus must make loads of profit which means miraculous cures are not made if they won’t make money. The chosen drug then goes on to be licensed and patented.
Around 5000 compounds start the preclinical stage
Only 50 make it to testing on healthy volunteers
And then 5 are given to ill patients.
And only one out of the initial 5000 is to be sold.
The whole process takes: 15 yrs
And costs: £ 500,000,000
Which is why drugs tend to cost a ridiculously high as after the patent has expired any company can make your drug, forcing companies to try to get back the 500 mil they invested before the expiry date. It’s a tough world out there.